(76 days)
PQ 1 PermaQuick Bonding System is used for 95% of bonding needs in restorative dentistry. Ease of use I Q 1 t offinaQuick Donaling Cycleral as PQ 1 the agent of choice for all light cure bonding needs. PQ 1 is conducive for bonding to:
-
- Dentin and Enamel using composite or amalgam.
-
- Porcelain
-
- Metal
-
- Composite repair
Not Found
I apologize, but the provided text is a letter from the FDA regarding a medical device, not a study describing its acceptance criteria and performance. Therefore, I cannot extract the requested information, as the document does not contain details about:
- Acceptance criteria and reported device performance in a table format.
- Sample sizes, data provenance, number of experts, or ground truth establishment for test sets.
- Adjudication methods.
- MRMC comparative effectiveness studies or standalone algorithm performance.
- Training set sample size or ground truth establishment.
The document primarily focuses on the FDA's substantial equivalence determination for the "PQ 1 PermaQuick Bonding System" and its intended uses.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting care and support. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 9 1998
Mr. Chester McCoy Requlatory Affairs Manager Ultradent Products, Incorporated 505 W. 10200 South 84065 South Jordan, Utah
K974283 Re : Trade Name: PQ 1 Requlatory Class: II Product Code: KLE Dated: November 10, 1997 November 14, 1997 Received:
Dear Mr. McCoy:
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, Drug, 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 reqistration, listing of devices, good manufacturing practice, labelinq, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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
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Page 2 - Mr. McCoy
not affect any 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) 594-4618. 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 requlation 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.qov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Directpr Divisibn of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 17, | 18CC | |
|---|---|---|
| ----- | -------------- | -- |
510(k) Number (if known):
Device Name: _PQ 1
Indications For Use:
PQ 1 PermaQuick Bonding System is used for 95% of bonding needs in restorative dentistry . Ease of use I Q 1 t offinaQuick Donaling Cycleral as PQ 1 the agent of choice for all light cure bonding needs. PQ 1 is conducive for bonding to:
-
- Dentin and Enamel using composite or amalgam.
-
- Porcelain
-
- Metal
-
- Composite repair
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Risser
Division Sign. Off.
(Division Sign-Off) Division of Dental. Infection Control, and General Hospital Devices 510(k) Number .
Prescription Use
(Per 21 CFR §01.109) Yes
OR
Over-The-Counter Use الم
(Optional Format 1-2-96)
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.