AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN

K070699 · Pentron Ceramics, Inc. · EIH · Jun 29, 2007 · Dental

Device Facts

• Record ID: K070699
• Device Name: AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN
• Applicant: Pentron Ceramics, Inc.
• Product Code: EIH · Dental
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Avante® Z is an all-ceramic dental restoration system used by a trained dental technician in a dental laboratory to create crowns (anterior and posterior), inlays, onlays, and veneers, with or without Zirconium Oxide (ZrO2) cores.

Device Story

Avante Z System is an all-ceramic dental restoration system; used by trained dental technicians in dental laboratories. System facilitates fabrication of crowns, inlays, onlays, and veneers; supports use with or without Zirconium Oxide (ZrO2) cores. Device provides materials/components for dental restoration construction; final restorations are placed by dentists to restore patient tooth structure/function. Benefits include aesthetic and functional tooth replacement.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

All-ceramic dental restoration system; includes Zirconium Oxide (ZrO2) components. Intended for laboratory fabrication of dental prosthetics. Class II device under 21 CFR 872.6660.

Indications for Use

Indicated for use by trained dental technicians in dental laboratories to fabricate all-ceramic dental restorations, including anterior and posterior crowns, inlays, onlays, and veneers, utilizing Zirconium Oxide (ZrO2) cores or as standalone ceramic restorations.

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)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 9 2007

Ms. Megan Vernak Quality Systems Supervisor Pentron Ceramics, Incorporated 500 Memorial Drive Somerset, New Jersey 08873

Re: K070699

Trade/Device Name: Avante Z System Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: June 4, 2007 Received: June 7, 2007

Dear Ms. Vernak:

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. Vernak

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,

Susan Russo

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

510(k) Number (if known): K070699

Device Name: Avante Z System

Indications For Use:

Avante® Z is an all-ceramic dental restoration system used by a trained dental technician in a dental laboratory to create crowns (anterior and posterior), inlays, onlays, and veneers, with or without Zirconium Oxide (ZrO2) cores.

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)

Susan Rose

( Tision Sign-Off) Division of Anesthesiology, General Hos Infection Control, Dental D

510(k) Number: k070699

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