(38 days)
Not Found
Not Found
No
The device description and intended use clearly describe a dental porcelain powder used in traditional dental laboratory processes. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device, a dental porcelain powder, is used by dental technicians to fabricate custom dental restorations (prostheses). It is a component and material for the creation of a medical device, but it is not directly applied to a patient for a therapeutic purpose itself. The finished dental restoration would be considered a therapeutic device if it is meant to restore function or correct a condition.
No
Explanation: The device is a dental porcelain powder used to construct dental restorations, not to diagnose a condition or disease.
No
The device description explicitly states it is comprised of "dental porcelain powder" and "blanks," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is used by dental technicians to construct dental restorations (prostheses) for patients. This is a process of fabricating a medical device that will be placed in the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is dental porcelain powder used in laboratory processes to create dental devices. This aligns with the fabrication of a medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVDs are typically used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's purpose is to create a physical restoration for a patient's mouth.
N/A
Intended Use / Indications for Use
The device is indicated for use by dental technicians in the construction of custom porcelain (ceramic) and porcelain (fused to metal) dental restorations for anterior and posterior locations.
For use in prosthetic dentistry to create porcelain (ceramic) and porcelain (fused-to-metal) prostheses.
For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.
Product codes
EIH
Device Description
The device is comprised of dental porcelain powder that is used in the form of powder or blanks as a part of dental laboratory processes that are used to fabricate porcelain (ceramic) and porcelain (fused-to-metal) dental devices that are custom fitted to conform precisely to patients' models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior locations (for dental restorations)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technicians, dental professional such as a DDS or DMD
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)
Not Found
Reference Device(s)
Not Found
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
MAR 3 - 2005
510(k) Summary
Submitter: Glidewell Laboratories 4141 MacArthur Blvd. Newport Beach, CA 92660
Contact Person Keith D. Allred 949-440-2683 949-440-2787 (fax)
Date of Application: January 11, 2005
Device Name:
- · Trade Name Prismatik™ Ceramic
- · Common Name Porcelain powder for clinical use
- · Classification II
- · Product Code EIH
Description: The device is comprised of dental porcelain powder that is used in the form of powder or blanks as a part of dental laboratory processes that are used to fabricate porcelain (ceramic) and porcelain (fused-to-metal) dental devices that are custom fitted to conform precisely to patients' models.
Intended Use: The device is indicated for use by dental technicians in the construction of custom porcelain (ceramic) and porcelain (fused to metal) dental restorations for anterior and posterior locations.
Substantial Equivalence: The device is substantially equivalent to other legally marketed devices in the United States. Substantially equivalent devices include the following: Avante Micro Crystal® and OPC® Porcelain (Jeneric/Pentron) and Cerabien ZR Porcelain (Noritake).
Safety and Efficacy: The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comparative devices are minor and do not raise new safety concerns. The effectiveness and suitability to the intended purpose of the device is assured through wide, general use of similar other predicate devices, and demonstrates the safe use of the device to construct dental restorations.
1
Public Health Service
Image /page/1/Picture/2 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle, following its curvature. The text is in all capital letters and appears to be in a sans-serif font.
MAR 3 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Keith D. Allred Glidewell Laboratories 4141 MacArthur Boulevard Newport Beach, California 92660
Re: K050144
Trade/Device Name: Prismatik™ Ceramic Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: January 11, 2005 Received: January 24, 2005
Dear Mr. Allred:
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.
2
Page 2 - Mr. Allred
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 nfour that I 22 x y Federal statutes and regulations administered by other Federal agencies. ox the Fet of any I outh 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 and instille (s 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), n Jose contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mav 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 vours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K05 0/44
Schedule B
Sample Device Label/Indications for Use Statement
- 510(k) Number (if known): ♪
- Device Name: Prismatik™ Ceramic ア
- Indications for Use: す
For use in prosthetic dentistry to create porcelain (ceramic) and porcelain (fused-to-metal) prostheses.
For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.
Susan Runover
vision Sign-Off) . sion of Anesthesiology, General Hospital, rection Control, Dental Devices
Number: K850144