CERCON BASE

K013230 · Degussa - Ney Dental, Inc. · EIH · Oct 25, 2001 · Dental

Device Facts

• Record ID: K013230
• Device Name: CERCON BASE
• Applicant: Degussa - Ney Dental, Inc.
• Product Code: EIH · Dental
• Decision Date: Oct 25, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density. It is designed for use as a substructure (framework) for single tooth or bridge type restorations. Applications include both anterior and posterior locations.

Device Story

Cercon Base consists of partially sintered yttria-stabilized zirconia powder. Device is machined by dental laboratory technicians to create custom dental frameworks; subsequently sintered to full density. Final product serves as substructure for single tooth or bridge restorations. Used in dental clinics/laboratories; intended for prescription use. Provides high-strength ceramic framework for restorative dentistry.

Clinical Evidence

No clinical data provided; substantial equivalence based on material properties and intended use as a dental ceramic substructure.

Technological Characteristics

Material: Yttria (yttrium oxide) stabilized zirconia (zirconium oxide). Form: Partially sintered powder for machining, followed by sintering to full density. Application: Dental substructure/framework.

Indications for Use

Indicated for use as a substructure (framework) for single tooth or bridge type dental restorations in both anterior and posterior locations.

Regulatory Classification

Identification

Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing its wings or body. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Public Health Service

OCT 2 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thomas B. Cameron, Ph.D. Official Correspondent Director of Technical Services/R&D Degussa-Ney Dental, Incorporated 65 West Dudley Town Road Bloomfield, Connecticut 06002-1316

Re: K013230

Trade/Device Name: Cercon Base Regulation Number: 21 CFR 872.6660 Regulation Name: Dental Ceramic Regulatory Class: Class II Product Code: EIH Dated: September 26, 2001 Received: September 27, 2001

Dear Dr. Cameron:

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.

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.

{1}------------------------------------------------

Page 2 - Dr. Cameron

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely,

Tim A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## KO13230

510(k) Number (if known):

CERCON BASE Device Name:

Indications for Use:

Cercon Base is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is machined and then sintered to full density. It is designed for use as a substructure (framework) for single tooth or bridge type restorations. Applications include both anterior and posterior locations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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

510(k) Number Ko/3230

OR

Over-The-Counter Use

(Optional Format 1-2-96)