(130 days)
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.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a dental device, "Bettini BZD Zirconia Blocks." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
This type of document primarily confirms that the FDA has reviewed the device and determined it is "substantially equivalent" to legally marketed predicate devices. This determination is based on the information provided by the manufacturer in their 510(k) submission, which would typically include technical specifications, comparisons to predicate devices, and sometimes performance data, but that detailed study information is not present in this letter.
Therefore, I cannot provide the requested information based on the input document.
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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.
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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 (800) 638-2041 or (301) 796-7100 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
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Indications For Use
Applicant: Bettini S.p.A.
: ..
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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:
§ 872.6660 Porcelain powder for clinical use.
(a)
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.(b)
Classification. Class II.