CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA

K113431 · Bettini S.P.A. · EIH · Mar 30, 2012 · Dental

Device Facts

• Record ID: K113431
• Device Name: CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA
• Applicant: Bettini S.P.A.
• Product Code: EIH · Dental
• Decision Date: Mar 30, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bettini BZD Zirconia Blocks are indicated for use in preparation of crowns, facings, inlays, and onlays to produce a hard prosthesis with a porcelain-like finish. The blocks are frequently used with porcelain overlay for translucence and related effects, and they are utilized to fabricate copings and frameworks for inlays, onlays, veneers, crowns, and anterior and posterior bridge restorations.

Device Story

Bettini BZD Zirconia Blocks are dental ceramic materials used by dental professionals to fabricate prosthetic restorations. The blocks serve as the base material for crowns, bridges, inlays, onlays, and veneers. The material is milled or shaped to form a hard, durable framework or coping, which may be finished with a porcelain overlay to achieve desired aesthetic translucency and anatomical form. The device is used in a dental laboratory or clinical setting to produce custom prostheses that restore tooth function and appearance. The final output is a dental restoration that provides structural support for the patient's dentition.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Zirconia-based ceramic blocks for dental CAD/CAM or manual milling. Material is a high-strength ceramic intended for prosthetic frameworks. No specific ASTM standards or software components described.

Indications for Use

Indicated for dental patients requiring restorative procedures including crowns, facings, inlays, onlays, veneers, and anterior/posterior bridge restorations. Used to fabricate copings and frameworks.

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 Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Bettini S.p.A. C/O Mr. Claude Berthoin President Thema USA 110 E. Granada Blvd. Suite 207 Ormond Beach, Florida 32176

MAR 3 0 2012

Re: K113431

Trade/Device Name: Bettini BZD Zirconia Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: II Product Code: EIH Dated: March 12, 2012 Received: March 15, 2012

Dear Mr. Berthoin:

We have reviewed vour 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

## Page 2 - Mr. Berthoin

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications For Use

Applicant: Bettini S.p.A.

: ..

3-1 :: ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Bettini BZD Zirconia Blocks

Indication For Use:

Bettini BZD Zirconia Blocks are indicated for use in preparation of crowns, facings, inlays, and onlays to produce a hard prosthesis with a porcelain-like finish. The blocks are frequently used with porcelain overlay for translucence and related effects, and they are utilized to fabricate copings and frameworks for inlays, onlays, veneers, crowns, and anterior and posterior bridge restorations.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE).

Division Sian-Off Office of Device Evaluation

510(k)

Suan Ruson

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

510(k) Number: