PREPQUICK

• K Number: K974786
• Device Name: PREPQUICK
• Manufacturer: ULTRADENT PRODUCTS, INC.
• Date Cleared: 1998-03-03 ( 71 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

PrepQuick has shown to be an effective means for selective removal of smear layer prior to cementation, e.g., glass ionomers and polycarboxylate cements or restoratives.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "PrepQuick." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The letter is a regulatory approval, not a scientific study report.

Therefore, I cannot provide the requested information. The sections of your request remain unanswered based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the document.
2. Sample size used for the test set and the data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
4. Adjudication method: Not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not relevant, as this is not an AI/imaging device and no human reader study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant, as this is not an algorithm/software device.
7. The type of ground truth used: Not provided in the document.
8. The sample size for the training set: Not provided in the document.
9. How the ground truth for the training set was established: Not provided in the document.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 1998

Mr. Chester McCov Requlatory Affairs Manager Ultradent Products, Incorporated 505 W. 10200 South South Jordan, Utah 84065

Re: K974786 Trade Name: PrepQuick Requlatory Class: II Product Code: KLE Dated: December 18, 1997 Received: December 22, 1997

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 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 Requlations, Title 21, Parts 800 to 895. ਚੋ 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 Drug 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. McCoy

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 leqally 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timoth A. Ulatowski 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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510(k) Number (if known): Unknown________________________________________________________________________________________________________________________________________

Device Name: _PrepQuick

Indications For Use:

. ·

PrepQuick has shown to be an effective means for selective removal of smear layer prior to cementation, e.g., glass ionomers and polycarboxylate cements or restoratives.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number	974784
Prescription Use	✓
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_
(Optional Format 1-2-96)

Regulation Number and Section

§ 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.