(76 days)
For use as a milling blank in the fabrication of provisional crowns and bridges.
Discs of PMMA in two sizes and three shades for milling into provisional crowns and bridges
The provided text describes a 510(k) premarket notification for a dental device, specifically a "Wieland Zeno CAO temporary PMMA disc, tooth-colored." This device is a material for fabricating provisional crowns and bridges, not an AI/ML powered device. As such, the concept of "acceptance criteria for an AI device" and the associated study characteristics (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to the information provided in this document.
The document states that the device was tested for compliance to ISO 3336 and ISO 10993. These are standards for dental materials and biocompatibility, respectively. The acceptance criteria would be defined by these ISO standards, and the "study" would be the testing performed to demonstrate compliance with these material properties and safety standards.
Therefore, I cannot fulfill the request as formatted for an AI/ML powered device using the given text. The information required (e.g., number of experts, adjudication methods, AI performance metrics) is simply not present because the device is a physical dental material and not a software-based diagnostic or analytical tool.
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Premarket Notification Temporary Crown and Bridge Material
:
:
Merz Dental GmbH Lütjenburg, Germany
VIII. Premarket Notification 510(k) Summary
| Submitted by: | Merz Dental GmbHEetzweg 20D-24321 LutjenburgGermany0 43 81/4 03-4 11 (phone)0 43 81/4 09-1 07 (fax)AUG 2 1 2007 |
|---|---|
| Contact person: | Dr. Med Claudia Bobrowski |
| Date prepared: | June 1, 2007 |
| Device proprietary name: | Wieland Zeno CAO temporary PMMA disc,tooth-colored |
| Common name: | PMMA Crown and Bridge Material |
| Classification name: | Temporary Crown and Bridge Resin(21 CFR 872.3770) |
| Predicate devices: | artegral® ImCrown,Merz Dental (K061809)Temporary Crown and Bridge Material,Dentsply International (K060293) |
| Description of the device: | Discs of PMMA in two sizes and three shadesfor milling into provisional crowns and bridges |
| Intended use: | For use as a milling blank in the fabrication ofprovisional crowns and bridges. |
| Characteristics: | An ideal material for the fabrication ofprovisional crowns and bridges because of itsstrength, ease of milling, dimensional stability,and natural esthetic. |
| Testing:10993 | Tested for compliance to ISO 3336 and ISO |
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Image /page/1/Picture/11 description: The image shows a circular seal or logo. The text around the top of the circle reads "HUMAN SERVICES - USA". The text around the bottom of the circle reads "DEPARTMENT OF HEALTH & ". Inside the circle is a stylized graphic, possibly representing a flag or a symbol of the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2007
Merz Dental GmbH C/O Mr. Richard G. Hunter Principal Washington Regulatory Consultants 5616 Mariola Place, NE Albuquerque, New Mexico 87111
Re: K071548
Trade/Device Name: Wieland Zeno CAO Temporary PMMA Disc, Tooth-Colored Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: August 3, 2007 Received: August 13, 2007
Dear Mr. Hunter:
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.
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Page 2 - Mr. Hunter
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" (21CFR 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,
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
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Merz Dental GmbH Lütjenburg, Germany
V. Indications for Use Statement
510(k) Number: To be assigned K071548
Device Name:
Wieland Zeno CAO temporary PMMA disc, tooth-colored
Indications for Use:
For use as a milling blank in the fabrication of provisional crowns and bridges.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart ) ________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susar Runne | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K071548 |
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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.