(120 days)
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Not Found
No
The summary describes a PMMA blank for CAD/CAM manufacturing, with no mention of AI or ML in the intended use, device description, or any other section.
No
The device is a PMMA blank used for manufacturing temporary dental restorations, not a therapeutic device itself. It's a material used in the creation of a dental device, but doesn't directly provide a therapeutic effect.
No
The device is described as a blank for manufacturing temporary crowns and bridges. Its function is to be processed by a CAD/CAM system to create a physical dental prosthetic, not to diagnose a condition or disease.
No
The device description clearly states it is a PMMA blank, which is a physical material used for manufacturing, not software.
Based on the provided information, the VIPI Block is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to manufacture temporary crowns and bridges. This is a dental restorative application, not a diagnostic test performed on samples taken from the human body.
- Device Description: The device is a PMMA blank, which is a material used for fabrication, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the VIPI Block is a dental material used in the fabrication of temporary restorations, not an IVD.
N/A
Intended Use / Indications for Use
The VIPI Block is a PMMA blank for manufacturing temporary crowns and bridges by a CAD/CAM system.
Product codes
EBG
Device Description
The VIPI Block is a PMMA blank for manufacturing temporary crowns and bridges by a CAD/CAM system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3770 Temporary crown and bridge resin.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized human figure embracing the world. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The text is in all capital letters and is evenly spaced around the circle.
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.
1
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 (800) 638-2041 or (301) 796-7100 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
2
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)
・
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