Instructions for use

General Description

Blacksmithwave Abutment is made of titanium alloy (Ti-6Al-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration.
It consists of Pre-Milled Blank and Ti-Base abutment. It has a premanufactured connection interface that fits directly to an endosseous dental implant.

Pre-Milled Blank Design Limitation for Patient-specific abutment:

Design parameter (Patient-specific abutment)Subject SystemDesign Limit
Minimum and Maximum Gingival (Cuff) Height0.5~5mm
Minimum and Maximum diameter at abutment/implant interface∅4.0~∅8.0
Minimum and Maximum length of abutment4.5~13mm
Minimum and Maximum length of abutment post(length above the abutment collar/gingival height)4~8mm
Minimum wall thickness at abutment/implant interface0.4mm
Minimum and Maximum abutment angle0~25º

Blacksmithwave Abutment is made of titanium alloy (Ti-6Al-4V ELI, ASTM F136) intended for use as an aid in prosthetic restoration.
It consists of Pre-Milled Blank and Ti-Base abutment. It has a premanufactured connection interface that fits directly to an endosseous dental implant.

Pre-Milled Blank Design Limitation for Patient-specific abutment:

Ti Base consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a
CAD/CAM-designed zirconia superstructure (the second part of the two-piece abutment) that composes the final abutment.
Pre-Milled Blank and Ti Base are provided non-sterile therefore must be sterilized after the cementation of the patient-specified superstructure.

Raw material blanks

• InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664.
Cement

• RelyX Unicem 2Automix by 3M ESPE, cleared under K100756.

Design ParameterLimit(Min.~Max.)
Minimum and Maximum abutment angle0~15
Minimum and Maximum Gingival (Cuff) Height0.5~5.0
Minimum and Maximum length of abutment post(length above the abutment collar/gingival height)4.0~6.0
Minimum and Maximum diameterat abutment/implant interface5.0~8.0
Minimum wall thickness at abutment/implant interface0.4

Blacksmithwave Abutment is a device that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.

[APPLICATIONS AND METHOD OF USE]

Lab Analog
The analogues are used to simulate the connection of the dental implant and position it in a plaster
model and 3D-printed model.
Before any manipulation make sure that the anti-rotational and retention parts are securely connected.
Before pressing, check that the analog and prosthesis match in size and type of connection. When
contracting with 3D printing models, “clicking” assures complete Insertion. Do not reuse an analog
again, because such a connection can be altered and your technical specifications modified.

Scan Body
Scan Body abutments are used for prosthetic restorations prepared by dental technicians in dental laboratories or by dentists at in the CAD/CAM process.
Designed to obtain geometric data from the master model using a desktop laboratory 3D scanner or for optical impressions using an intraoral 3D scanner.
For proper processing a BlacksmithwaveⓇ digital library is needed. To download and install one of our libraries specific to your dental CAD system please visit our website https://www.blacksmithwave.com Before scanning the abutment and analogue they should be visually checked for surface damage or implant connection for any tissue residue.

Ti-Base
The Ti-Base is used for prosthetic restorations prepared by dental technicians in a dental laboratory.
To use this product in digital dentistry, the BlacksmithwaveⓇ library and a scan body abutment are needed. To download and install one of our libraries specific to your dental CAD system please visit our website https://www.blacksmithwave.com dental CAD/CAM systems. To improve cement adhesion, we recommend that it be thoroughly cleaned and degreased before cementation.
For secure grip the diameter and height of the Ti-Base should not be reduced.

Pre-milled Blank
Pre-milled Blank are used for prosthetic restorations prepared by dental technicians in dental laboratories.
The pre-milled Blank of the blank is fabricated to Patient-specific abutment.
The abutment shape can be milled with burs to meet specific.
Total millable length : 20 mm 
Minimal gingival transition : 0.2mm 

Abutment Screw
The screw is for fixing prosthetic restorations and auxiliary abutments over the implant or analogue.
– Use the suitable model and size for tightening and unscrewing.
– Make sure the correct model of screw is used for each case.
– Avoiding excessive torque, and prevent the implant from turning while screwing.
– When transferring to the patient, do not use the same screw that was used in the laboratory.
– Position the patient to avoid aspiration should the screw fall during screwing/unscrewing..

1. Indication for Use

Blacksmithwave Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

It is compatible with the following systems:

Compatible SystemImplant Body Diameter
(mm)
Implant
Platform
Osstem TS (K121995)3.5, 3.75Mini
3.75, 3.77, 4.2, 4.25, 4.4, 4.6,4.63, 4.65, 4.9, 5.05,5.08, 5.1Regular
Straumann Bone Level
(K140878)
3.3NC
4.1, 4.8RC
Dentium SuperLine
(K160965)
3.6, 4.0, 4.5, 5.0, 6.0Regular
Megagen AnyRidgeⓇ
(K140091)
3.5, 4.0, 4.5, 5.0Regular
Nobel Active 3.0
(K102436)
3.03.0
Nobel Active Internal
Connection Implant
(K071370)


3.5NP
4.3, 5.0RP
5.5WP
Screw VentⓇ and Tapered
Screw VentⓇ (K013227)


3.7, 4.13.5
4.74.5
6.05.7

All digitally designed abutments for use with Blacksmithwave Abutments are intended to be sent to a Blacksmithwave validated milling center for manufacture.

2. Design Specification

Design ParameterLimit(Min.~Max.)
Minimum and Maximum Gingival (Cuff) Height0.5~5mm
Minimum and Maximum diameter atabutment/implant interface∅4.0~∅8.0
Minimum and Maximum length of abutment6~12mm
Minimum and Maximum length of abutment post (length above the abutment collar/gingival height)4~8mm
Minimum wall thickness at abutment/implant interface0.39~0.55mm
Minimum and Maximum abutment angle0~25º

4. Cautions when using the product

  1. The product must be used by an appropriately trained professional. Damaged tools should not be used. Arbitrarily changing or modifying the product is not-recommended and will void the lifetime warranty of the abutments.
  2.  Prior to fabrication and delivery of prosthesis, confirm osseointegration of the implants by utilizing X-ray imaging and percussion testing.
  3.  A working model is produced after obtaining impressions. The working model should be carefully utilized during the laboratory process, together with the appropriate prosthetic components, in order to achieve functional occlusal surfaces between the upper and lower jaw.
  4. Temporary prosthesis should be carefully adjusted for the condition of the patient’s oral cavity, especially until the implants prove to be osseointegrated.
  5.  No cement should be applied to the Morse taper area between fixtures and abutments.

3. How to use the product

  1. After osseointegration has been successfully achieved for the fixture, design an appropriate CAD/CAM patient-specific abutment suitable to the oral environment.
  2. Reproduce the configuration of the oral cavity of the patient through impression taking and send the impression to a dental laboratory to fabricate the final prosthesis. Once the final prosthesis fabrication is completed, deliver it to the patient to improve their masticating and aesthetic functions.
  3. When affixing an abutment onto a fixture, the recommended torque value is equivalent to the manufacturers’ value for the respective implant system. The torque value should be determined based on the clinical assessment of the bone quality, fixture dimensions, and prosthesis type, etc.
  4. When affixing the abutment onto a compatible fixture, please refer to the original equipment manufacturers implant system labeling for surgical techniques and considerations for placement.

5. Side Effects

Allergies or sensitivities connected with the alloy cannot be ruled out in very rare isolated cases.

6. Interactions

Different alloy types in the same mouth can, in the event of occlusal or approximal contact, lead to galvanic reactions.

7. Proper storage and care

After sterilization, place the devices in a dry dark place such as a closed cupboard or drawer. Follow the instructions of the manufacturer of the FDA-cleared pouches regarding storage conditions and expiration date of sterilized goods.

8. Cleaning, disinfection and sterilization

Blacksmithwave Abutment is for one-time use only and provided non-sterile therefore must be sterilized prior to use.
All Blacksmithwave Abutment components are cleaned using multiple sessions of ultrasonic baths to remove contaminants from the milling process.

  1. First session
    Immerse finished products into 1-BP at 30º C (86º F), running
    the process for 20 minutes.
     
  2. Second session
    Immerse products into distilled water at 30º C (86º F), running
    the process for 20 minutes.
     
  3. Third session
    Immerse products into solujet at 30º C (86º F), running the
    process for 20 minutes.
     
  4. Fourth session
    Immerse products into distilled water at 30º C (86º F), running
    the process for 20 minutes and steam cleaning.

Rinsing:
Whether mechanical or manual cleaning has been performed, the device should be thoroughly rinsed to ensure that loosened debris and detergents are adequately removed. Tap water can be used for rinsing to ensure that copious volumes are used but since the quality of tap water varies considerably by region, the final rinse should be performed with treated water that is of a quality that does not contribute to staining or contamination.

All Blacksmithwave Abutments are delivered in non-sterile conditions. The individual abutments must be sterilized prior to insertion. Use only the validated sterilization procedures specified below to sterilize individual abutments.
Ti-Bases and zirconia superstructure must be bonded before sending to the dental clinic. Dentist must sterilize the abutment before inserting it in the patient’s mouth.

MethodMoist heat sterilization
CyclePre-vacuum
Temperature270℉ (132℃)
Exposure4 minutes
Drying20 minutes in chamber

Source: ANSI/AAMI ST79 Table 5

Use only a FDA-cleared sterilization wrap, pouch, or other device that is designed to allow sterilant penetration and to maintain sterility.
All autoclaves/sterilizers should comply with the requirements of, and be validated, maintained, and checked in accordance with EN 285/EN 13060, EN ISO 17665, ANSI AAMI ST79.
 
According to EN ISO 17665, the final responsibility for validation of cleaning, disinfection and sterilization techniques and equipment lies directly with the end user. To ensure optimal processing, all cycles and methods should be validated.

9. Warning

The integrity of the product must be inspected before use.
If the packaging is damaged the product may not be used.
The descriptions are insufficient to allow immediate use of the abutments. Dental/technical skills and instruction in the handling of the abutments are also essential. Since the information conveyed orally, in writing or in practical seminars is based on tests and experience, it can only be considered as standard values.
If our products make product changes in relation to the design and composition, we will keep track of these changes and submit a new 510(k) according to “Deciding When to Submit a 510(k) for a Change to an Existing Device”
 
Loss of sterility due to inadequate storage could lead directly to patient harm, e.g. infection and loss of osseointegration.
Blacksmithwave abutments should be used directly after sterilization.

Rx Only Caution: U.S. Federal law restricts these devices for sale, distribution and use by, or on the order of, a dentist or physician

Warning: Small diameter implants and angled abutment are not recommended for the posterior region.

10. MR Safety Information

Patients with the Blacksmithwave abutment can safely undergo MR examinations only under very specific conditions, and scanning may cause injury to the patient. The patient may only be imaged by landmarking at least 30cm from the implant, or ensuring the implant is located outside of the RF coil. Full MRI safety information is available in the MRI safety information table which only include the “Blacksmithwave abutment” parameters with a Maximum Spatial Field Gradient of “30 T/m (3,000 gauss/cm”).

A patient with this device can be scanned safely in an MR system under the following conditions:

Device NameBlacksmithwave abutment
Static Magnetic FieldStrength (B0)≤ 3 .0 T
Maximum Spatial FieldGradient30 T/m (3 ,000 gauss/cm)
RF ExcitationCircularly Polarized (CP)
RF Transmit Coil Type

For body transmit coil, landmarking at least 30 cm from the implant, or ensuring the implant is located outside of the coil.Extremity T/R coils permitted.Excludes Head T/R coil.

Operating ModeNormal Operating Mode in the allowed imaging zone
Maximum Whole-BodySAR2 W/kg (Normal Operating Mode)
Maximum Head SARNot evaluated f or head landmark
Scan DurationNo specific constraints due to implant heating

Federal law restricts the sale of this device to or on the order of licensed dentists.

11. Labeling symbols

Do not re-use
Consult instructions for use
Product Non sterile
Caution
Temperature limit
MR Conditional
Prescription only
Catalogue number (Model number)
Batch code (Lot number)
Manufacturer

UNITED STATES DISTRIBUTOR:
Blacksmithwave
5866 S 194th st
Kent WA98032, USA
(206) 438-3441
info@blacksmithwave.com
www.blacksmithwave.com