ANKYLOS TEMPORARY ABUTMENT BALANCE
Device Facts
| Record ID | K073073 |
|---|---|
| Device Name | ANKYLOS TEMPORARY ABUTMENT BALANCE |
| Applicant | Dentsply International, Inc. |
| Product Code | NHA · Dental |
| Decision Date | Feb 12, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
Indications for Use
The ANKYLOS® Temporary Abutment Balance is an anatomical abutment indicated for the fabrication of provisional crowns or bridges over max. 2 bridge pontics. The ANKYLOS® Temporary Abutment Balance is a short-term provisional for esthetic soft-tissue contouring.
Device Story
ANKYLOS Temporary Abutment Balance is an anatomical dental abutment component of the ANKYLOS Dental Implant System. Used by dental professionals in a clinical setting to support the fabrication of provisional crowns or bridges (maximum 2 pontics). Functions as a short-term provisional device to facilitate esthetic soft-tissue contouring during the healing phase of implant treatment. Available in small (D5.5) and large (D7) sizes with varying gingival margins (1.5 and 3). Compatible with both straight and angled implant positions. The device is made of plastic material. It is a mechanical component; it does not involve software, algorithms, or electronic processing.
Clinical Evidence
Bench testing only. No clinical data provided. Biocompatibility testing for cytotoxicity was performed, and materials were found to be identical to those used in legally marketed devices.
Technological Characteristics
Anatomical dental abutment made of plastic material. Available in two diameters (D5.5, D7) and two gingival margin heights (1.5, 3). Designed for straight and angled implant positions. Biocompatibility confirmed via cytotoxicity testing. No electronic components, software, or energy sources.
Indications for Use
Indicated for patients requiring provisional crowns or bridges (up to 2 pontics) for esthetic soft-tissue contouring in the context of the ANKYLOS Dental Implant System.
Regulatory Classification
Identification
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
Predicate Devices
Submission Summary (Full Text)
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# FEB 1 2 2008 510(k) SUMMARY
K073073
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|----------------------------|------------------------------------------------------------------------------|
| DATE PREPARED: | October 29, 2007 |
| TRADE OR PROPRIETARY NAME: | ANKYLOS® Temporary Abutment Balance |
| CLASSIFICATION NAME: | Endosseous dental implant abutment (872.3630) |
| PREDICATE DEVICES: | FRIADENT® EsthetiCap Abutment, K050208<br>ANKYLOS® Balance Abutment, K041509 |
DEVICE DESCRIPTION: The ANKYLOS® Temporary Abutment Balance is part of the ANKYLOS® Dental Implant System. The temporary abutment is available in the sizes "small" (D5.5) and "large" (D7) and with the gingival margins of 1.5 and 3. The ANKYLOS® Temporary Abutment Balance can be used in straight and angled implant positions.
### INTENDED USE:
The ANKYLOS® Temporary Abutment Balance is an anatomical abutment indicated for the fabrication of provisional crowns or bridges over max. 2 bridge pontics. The ANKYLOS® Temporary Abutment Balance is a short-term provisional for esthetic soft-tissue contouring.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in the ANK YLOS® Temporary Abutment Balance have been used in legally marketed devices and/or were found safe for dental use. The ANK YLOS® Temporary Abutment Balance is made of plastic material. which has been evaluated and passed biocompatibility testing for cytotoxicity. The materials used for the ANKYLOS® Temporary Abutment Balance as well as the manufacturing methods are identical to legally marketed devices. Therefore it was determined that no additional biocompatibility testing for the final product was necessary.
We believe that the prior use of the components of the ANKYLOS® Temporary Abutment Balance in legally marketed devices, the performance data provided, and the previous biocompatibility tests support the safety and effectiveness of the ANKYLOS® Temporary Abutment Balance for the indicated uses.
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KC730173
### TRUTHFUL AND ACCURATE STATEMENT
(As Required by 21 CFR 807.87(k))
. . . . . . . .
I certify that, in my capacity as Director of Corporate Compliance and Regulatory Affairs of DENTSPLY International, I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.
Arlewis
Helen Lewis Director of Corporate Compliance and Regulatory Affairs
October 29, 2007
K_____________________________________________________________________________________________________________________________________________________________________________
ANKYLOS® Temporary Abutment Balance
000011
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing a sense of movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. The logo is presented in black and white.
#### Public Health Service
## FEB 1 2 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K073073
Trade/Device Name: ANKYLOS® Temporary Abutment Balance Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 5, 2008 Received: February 7, 2008
Dear Ms. Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
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Page 2 - Ms. Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Smith Y. Mickie Dud.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### INDICATIONS FOR USE
K073073
510(k) Number (if known):
Device Name: ANKYLOS® Temporary Abutment Balance
Indications for Use:
The ANKYLOS® Temporary Abutment Balance is an anatomical abutment which is indicated for the fabrication of provisional crowns or bridges over max. 2 bridge pontics. The ANKYLOS® Temporary Abutment Balance is a short-term provisional for esthetic soft-tissue contouring.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
10% /
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rosser
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073073
Premarket Notification
ANKYLOS® Temporary Abutiment Balance
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