(111 days)
This device is a ceramic blank for fabrication of dental restoration in anterior and posterior locations. This device is used for fabricating copings, crowns, inlays, veneers and bridges.
The device is a strong and esthetic dental ceramic blank that is used by dental laboratories for fabrication of dental prosthetics such as copings, crowns and bridges. The device is comprised mainly of zirconium oxide powder and is used by dental CAD/CAM systems currently available in the market. The device is initially manufactured in a partially sintered state and is milled to specifications using standard CAD/CAM milling machines by dental technicians. The milled units are then sintered fully to the final state that is capable of being used in dental restoration procedures by dentists.
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them.
The document is a 510(k) premarket notification letter from the FDA to A&D Dental Innovations, LLC regarding their PRISM Zirconia device. It primarily focuses on:
- FDA's substantial equivalence determination: Stating that the device is substantially equivalent to a legally marketed predicate device (Prismatik™ Clinical Zirconia, K060104).
- Regulatory information: Such as trade name, regulation number, classification, and general controls.
- Indications for Use: What the device is intended for.
- Device Description: General information about the device's material and manufacturing process.
- Substantial Equivalence justification: Briefly mentioning that performance testing (flexural strength, thermal expansion, solubility) was performed to establish substantial equivalence.
However, the document does not elaborate on:
- Specific acceptance criteria values for the performance tests.
- The actual reported device performance values against those criteria.
- Details about the study design: Such as sample size for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types.
- Information about training sets (sample size, ground truth establishment).
To answer your question thoroughly, I would need a more detailed study report or technical document that outlines the specific testing conducted, the quantitative results obtained, and the predefined acceptance criteria.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 9,2014
A&D Dental Innovations, LLC Mr. Yoonho Jun Project Manager 9308 Evening Primrose Path Austin, TX 78750
Re: K141659
Trade/Device Name: PRISM Zirconia Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: July 16, 2014 Received: July 16, 2014
Dear Mr. Jun:
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. Jun
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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4. Indications for Use
510(k) Number: K141659 Device Name: PRISM Zirconia Indications for Use:
This device is a ceramic blank for fabrication of dental restoration in anterior and posterior locations. This device is used for fabricating copings, crowns, inlays, veneers and bridges.
Prescription Use X_ Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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5. 510(k) Summary
1. Submitter
A & D DENTAL INNOVATIONS, L.L.C. 9308 EVENING PRIMROSE PATH AUSTIN, TX 78750 Phone: 1-888-374-5134 Fax: 1-888-374-5134 Contact: Yoonho Jun, Project Manager Date Prepared: July 10, 2014
2. Device Name
Trade Name: PRISM Zirconia Common Name: Zirconia dental blank Panel: Dental Classification Name: 21 CFR 872.6660: Porcelain powder for clinical use Class: Class II device Product Code: EIH
3. Predicate Devices
Prismatik™ Clinical Zirconia (Glidewell Laboratories, K060104)
4. Device Description
The device is a strong and esthetic dental ceramic blank that is used by dental laboratories for fabrication of dental prosthetics such as copings, crowns and bridges. The device is comprised mainly of zirconium oxide powder and is used by dental CAD/CAM systems currently available in the market. The device is initially manufactured in a partially sintered state and is milled to specifications using standard CAD/CAM milling machines by dental technicians. The milled units are then sintered fully to the final state that is capable of being used in dental restoration procedures by dentists.
5. Intended Use
This device is a ceramic blank for fabrication of dental restoration in anterior and posterior locations. This device is used for fabricating copings, crowns, inlays, veneers and bridges,
6. Technical Characteristics
PRISM Zirconia is designed to be the same as or similar to the predicate device in terms of intended use, material, chemical composition, dimensions and material properties. Both the submitting and predicate devices are manufactured by colloidal casting of zirconia powder. Both devices are dental ceramic discs with a diameter of 98 mm and composed of yttrium oxide stabilized zirconium oxide which is a common chemical composition for dental zirconia blanks. Any potential discrepancy in composition is with the minor dispersing agents, which are used during the manufacturing process and are released completely during the presintering process.
7. Substantial Equivalence
Performance testing including flexural strength, thermal expansion and solubility has been performed for the submitting and predicate devices to establish substantial equivalence to the predicate device. The testing results show that our PRISM Zirconia is substantially equivalent to the predicate device in terms of effectiveness and safety.
§ 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.