CERCON CERAM S PORCELAIN

K022796 · Dentsply Intl. · EIH · Sep 6, 2002 · Dental

Device Facts

• Record ID: K022796
• Device Name: CERCON CERAM S PORCELAIN
• Applicant: Dentsply Intl.
• Product Code: EIH · Dental
• Decision Date: Sep 6, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

CERCON® CERAM S PORCELAIN is for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include both anterior and posterior locations.

Device Story

CERCON® CERAM S PORCELAIN is a dental ceramic veneering material. It is applied to zirconia (zirconium oxide) substructures to create fixed prosthodontic restorations, including anterior and posterior crowns and bridges. The system comprises various porcelain types: Dentin, Transparent, Incisal, Liner, Opaque, Shoulder, and Correction/Glaze/Stain. The material is used by dental professionals in a laboratory or clinical setting to fabricate final dental restorations. It serves as a functional and aesthetic covering for the underlying zirconia framework.

Clinical Evidence

Bench testing only; biocompatibility testing for cytotoxicity was performed.

Technological Characteristics

Dental ceramic veneering material. Formulation modified from predicate. Components consist of Dentin, Transparent, Incisal, Liner, Opaque, Shoulder, and Correction/Glaze/Stain porcelains. Intended for application on zirconium oxide substructures.

Indications for Use

Indicated for use on zirconia (zirconium oxide) substructures for single tooth or bridge restorations in 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.

Predicate Devices

• Cercon® Ceram (K011333)

Submission Summary (Full Text)

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

# 510(k) SUMMARY

SEP 6 2002

NAME & ADDRESS:

**DENTSPLY International**
570 West College Avenue

KQ2794

P. J. Lehn Telefax [phone]

70 West College Avenue 0. Box 872 ork, PA 17405-0872 [phone]

P. Jeffery Lehn CONTACT:

DATE PREPARED: AUG 1 9 2002

TRADE NAME: CERCON® CERAM S PORCELAIN

(872.6660) Porcelain Powder for Clinical Use CLASSIFICATION NAME:

PREDICATE DEVICES: Cercon® Ceram K011333

CERCON® CERAM S PORCELAIN is a dental ceramic DEVICE DESCRIPTION: veneering material developed for veneering Cercon zirconia or an equivalent zirconium oxide substructure for fixed prosthodontics devices that include both anterior and posterior crowns/bridges.

The CERCON® CERAM S PORCELAIN System consists of Dentin/Transparent/Incisal, Liner/Opaque, Shoulder, and Correction/Glaze/Stain Porcelains. The final restoration matches more shades than the predicate device.

CERCON® CERAM S PORCELAIN is for use on zirconia (zirconium INTENDED USE: oxide) in single tooth or bridge type restorations. Applications include both anterior and posterior locations.

TECHNOLOGICAL CHARACTERISTICS: CERCON® CERAM S PORCELAIN represents a modification to Cercon® Ceram (K011333). Minor changes have been made in the device's formulation.

All of the components have been used in legally marketed devices. CERCON® CERAM S PORCELAIN was evaluated and passed biocompatibility testing for cytotoxicity.

We believe that the prior use of the components in legally marketed devices, the similarity in the formulations between the modified device and the marketed device, and the data provided regarding the modifications to the marketed device support the safety and effectiveness of CERCON® CERAM S PORCELAIN for the intended use.

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked one above the other.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

6 2002

Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872

Re: K022796

Trade/Device Name: Cercon® Ceram S Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 19, 2002 Received: August 23, 2002

Dear Mr. Lehn:

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.

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

Page 2 - Mr. P. Jeffery Lehn

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 vou 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 yours.

fo A. Wuton for

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

Enclosure

{3}------------------------------------------------

## INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known): KO2 2 791

## Device Name: CERCON® CERAM S PORCELAIN

Indications for Use:

Designed for use on zirconia (zirconium oxide) in single tooth or bridge type restorations. Applications include both anterior and posterior locations.

## (PLEASE DO NOT WRITE BELOW THIS LINE -----------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Saran Purser

ion Sign-On)
on of Anesthesiology, General Hospital, tion Control, Dental Devices

510(k) Number: KD222746

7