VIPI BLOCK

K102341 · Vipi Industria,Comercio,Exportacao E Importacao DE · EBG · Dec 16, 2010 · Dental

Device Facts

• Record ID: K102341
• Device Name: VIPI BLOCK
• Applicant: Vipi Industria,Comercio,Exportacao E Importacao DE
• Product Code: EBG · Dental
• Decision Date: Dec 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

The VIPI Block is a PMMA blank for manufacturing temporary crowns and bridges by a CAD/CAM system.

Device Story

VIPI Block is a PMMA (polymethyl methacrylate) blank used as raw material for CAD/CAM milling systems. Dental professionals use the device to fabricate temporary crowns and bridges. The blank is placed into a CAD/CAM milling machine, which removes material to create the final dental restoration shape based on digital design. The resulting temporary prosthesis is then placed in the patient's mouth to provide temporary coverage and function during the restorative process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Polymethyl methacrylate (PMMA) blank. Form factor: Solid block/disc for CAD/CAM milling. Intended for subtractive manufacturing of temporary dental prosthetics.

Indications for Use

Indicated for the fabrication of temporary crowns and bridges using CAD/CAM systems.

Regulatory Classification

Identification

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Submission Summary (Full Text)

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DEC 1 6 2010

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

VIPI Industria, Comercio, Exportacao E Importacao De Produtos Odontologicos Ltda. C/O Mr. Kevin Walls Regulatory Insight, Incorporated 5401 S. Cottonwood Court Greenwood Village, Colorado 80121

Re: K102341

Trade/Device Name: VIPI Block Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: December 6, 2010 Received: December 7, 2010

Mr. Walls:

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. 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. Walls

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Wh for

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

510(k) Number (if known): K102341

Device Name: VIPI Block

Indications for Use: The VIPI Block is a PMMA blank for manufacturing temporary crowns and bridges by a CAD/CAM system.

Prescription Use × (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 OF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runar

(Division Sign-Off) Division of Anesthesiology, General Hogspitabf 1 Infection Control, Dental Devices

510(k) Number: R102341