FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS

K072730 · Dentsply Intl. · NHA · Mar 27, 2008 · Dental

Device Facts

• Record ID: K072730
• Device Name: FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS
• Applicant: Dentsply Intl.
• Product Code: NHA · Dental
• Decision Date: Mar 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The FRIADENT® CERCON® Abutment is indicated for the support of exceptionally esthetic, single crowns in the anterior region of the maxilla or mandible region. Also ideal for XiVE®, FRIALIT® or FRIALIT®-2 cases involving very thin soft tissue. The ANKYLOS® CERCON® Abutment is indicated for the support of highly esthetic single tooth crowns in the anterior region of the maxilla and mandible, including where the mucosa is very thin, in combination with implants of the ANKYLOS® implant system.

Device Story

CERCON® Abutments are prosthetic components for dental implant systems; designed for support of single crowns in anterior regions. Available in straight and angled configurations with varying diameters, gingival margins, and shades. Fabricated from zirconia ceramic. Used by dental professionals in clinical settings to restore esthetics in patients with thin soft tissue. Device functions as a mechanical interface between the endosseous implant and the prosthetic crown. Benefits include improved esthetic outcomes in challenging soft tissue conditions.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence is based on material composition, design, and historical safety data of components used in legally marketed predicate devices.

Technological Characteristics

Materials: Zirconia ceramic. Form factor: Straight and angled abutments with varying diameters and gingival margins. Connectivity: Mechanical interface for dental implants. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for patients requiring support for single tooth crowns in the anterior maxilla or mandible, particularly in cases with thin soft tissue/mucosa, using compatible dental implant systems.

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

• FRIALIT®-2 CeraBase Abutment (K980630/K994376)
• ANKYLOS® Balance Abutment (K012681/K041509)

Submission Summary (Full Text)

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1072730

## 510(k) SUMMARY

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|----------------------------------------------------------------------------------------|
| DATE PREPARED: | |
| TRADE OR PROPRIETARY NAME: | CERCON® ABUTMENTS:<br>FRIADENT ® CERCON® Abutment<br>ANKYLOS® CERCON® Balance Abutment |
| CLASSIFICATION NAME: | Endosseous dental implant abutment |
| | 872.3630 |
| PREDICATE DEVICES: | FRIALIT®-2 CeraBase Abutment<br>ANKYLOS® Balance Abutment |
| | K980630/K994376<br>K012681/K041509 |

DEVICE DESCRIPTION: The CERCON® ABUTMENTS are part of the FRIADENT® prosthetics.

The CERCON® ABUTMENTS are available as straight and angled abutments with different gingival margins and in multiple diameters and shades.

INTENDED USE: The FRIADENT® CERCON® Abutment is indicated for the support of exceptionally esthetic, single crowns in the anterior region of the maxilla or mandible region. Also ideal for XiVE®, FRIALIT® or FRIALIT®-2 cases involving very thin soft tissue.

The ANK YLOS® CERCON® Abutment is indicated for the support of highly esthetic single tooth crowns in the anterior region of the maxilla and mandible, including where the mucosa is very thin, in combination with implants of the ANKYLOS® implant system.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in the CERCON® ABUTMENTS have been used in legally marketed devices or were found safe for derial use. They are made of zirconia ceramic in accordance with industry standards. In addition, the I hey are many of invonial to legally marketed devices. Therefore, it was determined that no additional biocompatibility testing was necessary.

We believe that the prior use of the components of the CERCON® ABUTMENTS in legally marketed devices, the provided, and the biocompatibility history support the safety and effectiveness of the CERCON® ABUTMENTS for the indicated uses.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. U.S.A.", arranged in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 2 7 2008

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: K072730

Trade/Device Name: Cercon® Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutments Regulatory Class: II Product Code: NHA Dated: February 12, 2008 Received: February 13, 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 Federal 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 (QS) 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Cure

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 STATEMENT

Ko 727 37 510(k) Number (if known):

Device Name: CERCON® ABUTMENTS

Indications for Use:

The FRIADENT® CERCON® Abutment is indicated for the support of exceptionally esthetic, single crowns in the anterior region of the maxilla or mandible region. Also ideal for XiVE®, FRIALIT® or FRIALIT®-2 cases involving very thin soft tissue.

The ANK YLOS® CERCON® Abutment is indicated for the support of highly esthetic single tooth crowns in the anterior region of the maxilla and mandible, including where the mucosa is very thin, in combination with implants of the ANKYLOS® implant system.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ko. Mahy for MCR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

40 510(k) Number:

CERCON® ABUTMENTS