(44 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, deep learning, or any related concepts, and the device description is not available.
No
The device is used for the production of dental restorations (inlays, onlays, veneers, crowns, and bridges) which are used in treatment but the device itself does not directly provide therapy.
No
The Intended Use statement explicitly describes the production of ceramic dental restorations, which is a manufacturing function, not a diagnostic one. There is no mention of identifying or detecting diseases or conditions.
Unknown
The provided text is a 510(k) summary template with no information filled in the "Device Description" section. Without a description of the device, it is impossible to determine if it is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Production of ceramic inlays, onlays, veneers, crowns & bridges using the Cerec machine." This describes a process for creating dental restorations, which is a manufacturing or fabrication process, not a diagnostic test performed in vitro (outside the body) on biological specimens.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health condition
- Using reagents or other materials typically associated with IVD tests
The device appears to be a tool used in a dental laboratory or clinic for the fabrication of dental prosthetics.
N/A
Intended Use / Indications for Use
Production of ceramic inlays, onlays, veneers, crowns & bridges using the Cerec machine
Product codes
EIH
Device Description
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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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an abstract image of an eagle with three heads. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2002
Dr. Horst Michael Birkhoff BB's Prophy Shop Grunstraße 2 41516 Grevenbroich-Wevelinghoven GERMANY
Re: K022408
Trade/Device Name: VITABLOCS® Mark II Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 24, 2002 Received: July 24, 2002
Dear Dr. Birkhoff:
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.
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.
1
Page 2 - Dr. Birkhoff
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
lottellutrshordn fer
Timothy A. Ulatowski 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
Page 1 of 6
510(k) Number (if known): K 022408
Device Name: VITABLOCKS
Indications for Use:
Production of ceramic inlays, onlays,
veneers, crowns & bridges using the
Cerec machine
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINGE ON ANOTHER PAGE IF NEEDED)
Prescription Use V (Per 21 CFR 801.109)
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Over-the-Counter Use
(Optional Format 1-2-96)
Course of the course of
Susan Ruane
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Intection Control, Dental Devices
510/k) Number