(49 days)
PA GEL 35% AND PA GEL 10% are indicated for use when etching of tooth dentin or enamel is required before bonding to the tooth structure. Ten percent concentration is indicated for either tooth dentin or enamel etching. Thirty-five percent concentration is indicated only for tooth enamel etching.
Not Found
I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them according to your requested format.
The document is a 510(k) clearance letter from the FDA for a dental etching gel (PA Gels 35% and 10%). While it states that the device is "substantially equivalent" to predicate devices, it does not provide:
- A table of acceptance criteria and reported device performance.
- Details of any specific study (sample sizes, data provenance, ground truth establishment, adjudication methods, number/qualifications of experts) for proving the device meets acceptance criteria. This type of detail is typically found in the 510(k) submission itself, not in the clearance letter.
- Information about MRMC comparative effectiveness studies or standalone algorithm performance, as this document is for a physical dental product, not an AI/software device.
- Sample sizes for training sets or how ground truth was established for them.
The letter focuses on regulatory clearance based on substantial equivalence, general controls, and good manufacturing practices, rather than detailed performance study results.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines above them that resemble wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1999
Ms. Mildred M. Goldstein, President Harry J. Bosworth 7227 North Hamlin Avenue Skokie, Illinois 60076
Re: K993716 PA Gel 35% in blue and PA Gel 10% in green Trade Name: or blue Regulatory Class: II Product Code: EBF October 27, 1999 Dated: Received: November 2, 1999
Dear Ms. Goldstein:
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 regulations 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) regulation (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 regulatory 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 - Ms. Goldstein
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 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 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
premarket notification" (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
Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(K) Number: K993716
Device Name: P A Gels 35% and 10%
INDICATIONS FOR USE:
PA GEL 35% AND PA GEL 10% are indicated for use when etching of tooth dentin or enamel is required before bonding to the tooth structure. Ten percent concentration is indicated for either tooth dentin or enamel etching. Thirty-five percent concentration is indicated only for tooth enamel etching.
Image /page/2/Picture/5 description: The image shows the word "CONFIDENTIAL" in large, bold letters. The word is slightly tilted upwards from left to right. The letters are somewhat faded and have a textured appearance, giving the impression that the word has been stamped or printed onto a surface.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
是非常的不同可能量的是用品不可是在的点面是可用可用的出租用用用
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-the-Counter Use(Optional Format 1/2/96) | |
|---|---|
| -------------------------------------------------- | -- |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | KA93716 |
|---|---|
| --------------- | --------- |
§ 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.