(56 days)
Zhermack OCCLUFAST CAD is a dental impression material intended to be placed on a dental patient's teeth for bite registration to reproduce the structure of a patient's teeth to provide models for study or for production of restorative prosthetic devices.
Occlufast CAD has been developed for use with CAD/CAM systems.
dental impression material
The provided document is an FDA 510(k) clearance letter for a dental impression material named Occlufast® CAD. This type of document primarily confirms that a new device is "substantially equivalent" to a predicate device already on the market, based on its indications for use and sometimes on performance data.
However, the letter does not contain any information regarding specific acceptance criteria for device performance, nor details of a study that proves the device meets such criteria. It's a regulatory clearance, not a technical performance report.
Therefore, I cannot provide the requested information from the given text. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test sets.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination typically relies on comparing the new device's technological characteristics and intended use to those of a predicate device, sometimes supported by basic performance testing to ensure safety and effectiveness are comparable, but detailed study reports and acceptance criteria are not typically included in the publicly available clearance letter itself.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 4 2008
Zhermack SpA C/O Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702
Re: K080130
Trade/Device Name: Occlufast® CAD Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: January 17, 2008 Received: January 18, 2008
Dear Mr. Shipps:
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. Shipps
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.
Snytte Y. Michiein Davis.
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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| ZhermackBEYOND INNOVATION |
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| 2 | INDICATIONS FOR USE | |
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| 510(k) Number (if known): | K080130 |
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Device Name: OCCLUFAST CAD
Indications for Use: Zhermack OCCLUFAST CAD is a dental impression material intended to be placed on a dental patient's teeth for bite registration to reproduce the structure of a patient's teeth to provide models for study or for production of restorative prosthetic devices.
Occlufast CAD has been developed for use with CAD/CAM systems.
Prescription Use______________________________________________________________________________________________________________________________________________________________ AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Susan Runner
Division Sign-Off) ivision of Anesthesiology, General Hospital fection Control, Dental Devices
KOXOBD________________________________________________________________________________________________________________________________________________________________________ 10(k) Number: __
OCCLUFAST CAD Rev. 1 Mar. 12, 2008
§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).