MODIFICATION TO: CERCON BASE

K051462 · Dentsply Intl. · EIH · Jun 24, 2005 · Dental

Device Facts

• Record ID: K051462
• Device Name: MODIFICATION TO: CERCON BASE
• Applicant: Dentsply Intl.
• Product Code: EIH · Dental
• Decision Date: Jun 24, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CERCON® BASE is indicated for crowns, multi-unit bridges, and inlay bridges. Applications include both anterior and posterior regions.

Device Story

CERCON® BASE is a dense ceramic substructure (framework) for dental restorations; composed of partially sintered yttria-stabilized zirconia (Y-TZP). Processed in dental laboratories by machining partially sintered Y-TZP blanks; sintered to near full density; veneered with dental ceramic. Used by dental professionals for single tooth or bridge restorations. Provides structural support for dental prosthetics; strength comparable to high-gold dental alloys. Benefits patient by providing durable, biocompatible ceramic framework for restorative dentistry.

Clinical Evidence

No clinical data provided. Substantial equivalence based on material safety and performance history of previously marketed devices.

Technological Characteristics

Oxide-based dense ceramic; partially sintered yttria-stabilized zirconia (Y-TZP). Form factor: machined blanks for crown/bridge frameworks. Strength comparable to high-gold dental alloys. Biocompatible. No software or electronic components.

Indications for Use

Indicated for patients requiring crowns, multi-unit bridges, or inlay bridges in anterior or posterior regions.

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 Base (K013230)

Submission Summary (Full Text)

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

## 510(k) SUMMARY

K05/462

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 JUN 2 4 2005 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|---------------------------------------------|
| DATE PREPARED: | May 26, 2005 |
| TRADE OR PROPRIETARY NAME: | CERCON BASE |
| CLASSIFICATION NAME: | Porcelain powder for clinical use, 872.6660 |
| PREDICATE DEVICES: | Cercon Base, K013230 |

#### DEVICE DESCRIPTION:

CERCON® BASE is a dense ceramic composed of partially sintered yttrial(yttrial(); })
{ if = = dense connect = (1 = (1 = = = = = = = = = = = = = = = = = = = = = = = = = = = = CERCON® BASE IS a dense colance connect (1-TZP). It is procesed in the dental laboratory by stablized zircomuni (zircomuni oxidc) powder (1 12 ). "It = pintered to near full density and then machining from a partially sincered 1-127 bank wines as anterior and posterior locations.
finally veneered with a dental veneering ceramic. It is designations CERCON® RASE finally veneered with a dellar vencemes cooth or bridge type restorations. CERCON® BASE is
as a substructure (framework) for single tooth or bridge type restorations. CERCON as a substructure (framowon) Tor easy - TZP products currently in the market.

INTENDED USE:

CERCON® BASE is indicated for crowns, multi-unit bridges, and inlay bridges. Applications include both anterior and posterior regions.

### TECHNOLOGICAL CHARACTERISTICS:

CERCON® BASE is an oxide-based dense ceramic composed of partially sintered ythis stabilized zirconia powder indicated for crown and bridge restorations. The strength of this material is similar to that of dental alloys containing high gold. The components of CERCON® material is sillinal to that of demanning containming and were found safe for dental use. Westigation BASE nave been used in previously marketed devices and the data provided beneve that the pror ass of carress of CERCON® BASE for the indicated uses.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2005

Ms. Helen Lewis Director, Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K051462

Trade/Device Name: Cercon® Base Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 26, 2005 Received: June 03, 2005

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bootion 910(t) production is substantially equivalent (for the indications for referenced above and nave accemined ate ed predicate devices marketed in interstate commerce use stated in the encreated to regary date of the Medical Device Amendments, or to devices that prof to May 20, 1770, inc chaoinent with the provisions of the Federal Food, Drug, and Cosmetic llave been reclassified in accordance with as proval application (PMA). You may, ACC (Act) that ao not require apple t to the general controls provisions of the Act. The general therefore, mailker the de rios, salf ov annual registration, listing of devices, good Controls provisions of clibeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

#### Page 2 - Ms. Helen Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA's Issualice of a substance or arther requirements of the Act or
that FDA has made a determination that your device arter Federal gegae . . You must that FDA has made a determination that your ac-ac-ac-a agencies. You must comply with any Federal statutes and regulations administered of teaching and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: registration and listi all the Act's requirements, including, but not innines to requirements as se forth in the quality labeling (21 CFR Part 801); good manufacturing inceller. the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product systems (QS) regulation (21 CF read of the Act); 21 CFR 1000-1050.
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)
The success of the Cases of a line of a location as af your device to legal This letter will allow you to begin maketing your article equivalence of your device to a legally
premarket notification. The FDA finding of sybstantial equivales of your de premarket notification. The FDA initing of substantial organities of the survey of the spermits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r the regulation and consemble of 2115 - Alance been note the requiries ant If you desire specific advice for your de not of 5. Also, please note the regulation entitled, and contact the Office of Compliance at [phone]. Your 2019. You may obtain other
"Misbranding by reference to premarket notification" (21 CFR Part of Stricipan of Strail "Misbranding by reference to premation ican its Act from the Division of Small general intormation on your responsibilities uner in to in toll-free number [phone] or Manufacturers, International and Consuner Assistance arous cdrib/industry/support/index.html.

Sincerely yours,

C. Liu, Ph.D.

Chiu S. Lin, PhD 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

510(K) Number (if known): K051462

CERCON® BASE Device Name:

Indications for Use:

CERCON® BASE is indicated for crowns, multi-unit bridges, and inlay bridges. Applications include both anterior and posterior regions.

.

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

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

7

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Pump

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

510(k) Number: K051462

CERCON® BASE