(86 days)
Primary tooth fillings Class I, III, and V fillings Wedge-shaped defects Class II semipermanent fillings
HYTAC® is classified as a tooth shade resin material (21 C.F.R. § 872.3690) because it is a device composed of methacrylates intended to restore carious lesions or structural defects in teeth.
The provided text is a 510(k) summary for a dental filling material called HYTAC®. It describes the device, the context for its re-submission to the FDA, and its indications for use. However, it does not include information on acceptance criteria, a study proving the device meets those criteria, or any details related to AI or algorithm performance. The document focuses on the regulatory aspects of changing the indications for use of an already cleared dental product.
Therefore, I cannot fulfill your request for information related to AI acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth as these concepts are not present in the provided text.
The text indicates:
- Device Name: HYTAC®
- Classification Name: Tooth shade resin material
- Common Name: Compomer filling material
- Intended Use: To restore carious lesions or structural defects in teeth.
- Expanded Indications: Class I, III, and V fillings, wedge-shaped defects, and Class II semipermanent fillings (up to two years). Previously limited to non-occlusal loaded fillings.
The change in indications for use was based on "good clinical experience, laboratory test data and comparison to DYRACT® AP by a study," but the specifics of that study (like acceptance criteria, sample size, etc.) are not detailed in this summary.
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
II.
| Name: | ESPE Dental AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Contact: | Dr. Andreas Petermann, Manager of U.S.Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | Andreas_Petermann@ESPE.de |
| Date: | August 27, 1999 |
| Name of Device | |
| Proprietary Name: | HYTAC® |
| Classification Name: | Tooth shade resin material |
| Common Name: | Compomer filling material |
| Predicate Device |
HYTAC® by ESPE................................................................................................................................................................
Dyract® AP by DENTSPLY........................................................................................................................................................
Description for the Premarket Notification
HYTAC® is classified as a tooth shade resin material (21 C.F.R. § 872.3690) because it is a device composed of methacrylates intended to restore carious lesions or structural defects in teeth.
Image /page/0/Picture/8 description: The image shows the text "510(k) HyTAC®" above the word "ESPE". To the left of the word ESPE is a logo that appears to be a tree. The registered trademark symbol is located to the right of the word HyTAC.
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On September 11, 1996 HYTAC® was 510(k)-cleared by the FDA. Because at that time no further clinical evidence was available, the range of indications was strictly limited to none-occlusal loaded fillings. Therefore, the information for use contained a contraindication phrase "HYTAC® is not indicated […] for long-term fillings in the permanent dentition exposed to occlusal loading".
However, good clinical experience, laboratory test data and comparison to DYRACT® AP by a study make it now possible in our point of view to expand the range of indications to occlusal loaded fillings, too. The above mentioned contraindication phrase will therefore be deleted in the Instructions for Use. The range of indications for HYTAC® will be expanded on permanent class I fillings and semipermanent class II fillings. The phrase "semipermanent" has to be understood as a period of up to two years.
Due to the 510(k) Memorandum #K97-1, released on January 10, 1997, "Deciding when to submit a 510(k) for a change to an existing device", deletion of a contraindication on one hand and expanding the range of indications on the other hand requires the submission of a new 510(k).
While the composition of HYTAC® remains still the same, in this 510(k) submission only the differences to the old submission are cited. Therefore, no chemical and toxicological data is contained to reduce unnecessary paperwork.
Image /page/1/Picture/4 description: The image shows the logo for 510(k) HYTAC ESPE. The logo is black and white and features the text "510(k) HYTAC" in a smaller font above the text "ESPE" in a larger font. There is a registered trademark symbol next to HYTAC. To the left of ESPE is a logo of a tree.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, represented by three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 1999
Dr. Andreas Petermann Manager, U.S. Regulatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld, Bavaria
K992909 Re : Hytac® Trade Name: Regulatory Class: II Product Code: EBF August 27, 1999 Dated: Received: August 30, 1999
Dear Dr. Andreas Petermann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Dr. Petermann
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asboing 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to ene rogaracion charion" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
(As Required by 21 C.F.R. § 801.109)
510(k) Number:
Device Name:
HYTAC®
Indications for use:
Primary tooth fillings Class I, III, and V fillings Wedge-shaped defects Class II semipermanent fillings
Prescription use: 17
Susan Runo
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devise Of Of 510(k) Number .
Over-the counter use □
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.