(183 days)
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.
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.
This document does not contain the information required to answer your request. The provided text is a 510(k) summary for dental abutments, which outlines the device description, intended use, and substantial equivalence to predicate devices, but does not describe any studies with acceptance criteria or performance metrics in the way you've outlined.
This submission is for a medical device (Cercon® Abutments) and, based on the provided text, the FDA classified it as substantially equivalent to existing predicate devices. This typically means that the device's technological characteristics and intended use are similar enough to already-approved devices that extensive new clinical studies with defined acceptance criteria and performance reporting might not have been necessary for the 510(k) clearance process itself. The summary states that "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." This suggests reliance on existing data for similar components, rather than new performance studies.
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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:FRIADENT ® CERCON® AbutmentANKYLOS® CERCON® Balance Abutment |
| CLASSIFICATION NAME: | Endosseous dental implant abutment |
| 872.3630 | |
| PREDICATE DEVICES: | FRIALIT®-2 CeraBase AbutmentANKYLOS® Balance Abutment |
| K980630/K994376K012681/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 (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 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
§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)