(29 days)
Not Found
Not Found
No
The 510(k) summary describes a dental ceramic material and its intended uses, with no mention of AI or ML technology in the intended use, device description, or any other section.
No
The device is a ceramic material used for fabricating dental prosthetics, which are restorative devices, not therapeutic devices. Therapeutic devices are typically used for treatment or prevention of disease.
No
The "Intended Use / Indications for Use" section describes the device as a ceramic material for fabricating dental restorations (inlays, veneers, crowns), which are treatments, not diagnostic procedures.
No
The device description and intended use clearly describe a physical ceramic material used for dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Vita PM7 pressable ceramic is used for fabricating dental restorations (inlays, onlays, crowns, veneers, etc.). These are physical devices used in the mouth, not for testing samples outside the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Vita PM7 pressable ceramic does not fit this definition.
N/A
Intended Use / Indications for Use
Vita PM7 pressable ceramic is to be used for the fabrication of
- Single and multi-surface inlays O
- Onlays o
- Veneers O
- Partial crowns
- Anterior crowns
- Premolar crowns o
Also for oxide-ceramic crown and bridge substructures to be veneered with conventional porcelain.
Product codes
EIH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
Description of the training set, sample size, data source, and annotation protocol
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2005
Ms. Barbara J. Lewandowski Regulatory Affairs Specialist VIDENT Incorporated 3150 East Birch Street Brea, California 92821
Re: K050362
Trade/Device Name: Vita PM7 Pressable Ceramic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 30, 2005 Received: February 14, 2005
Dear Ms. Lewandowski:
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.
1
Page 2 - Ms. Barbara J. Lewandowski
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); 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clare
Chiu S. Lin. PhD 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): K050362
Device Name: Vita PM7 Pressable Ceramic Indications for Use:
Vita PM7 pressable ceramic is to be used for the fabrication of
- Single and multi-surface inlays O
- Onlays o
- Veneers O
- Partial crowns ্
- Anterior crowns 0
- Premolar crowns o
Also for oxide-ceramic crown and bridge substructures to be veneered with conventional porcelain.
For use by or on the order of a dental professional such as DDS or DMD. Not for use by the general public or OTC.
× Prescription Use (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suan Runez
ுரமா Sign-Oif) Fion of Anesthesiology. General Hospital, reation Control. Dental Devices KOSBION
The Number ____
Page 1 of ____________________________________________________________________________________________________________________________________________________________________