PERMAFLO by ULTRADENT PRODUCTS, INC.

1. Anterior and posterior restorations, such as Class I, II, III, IV, and V.
1. Luting translucent inlays and onlays. Permalute (chemical cure) is recommended for more opaque or thick inlays/onlays where light cure is not predictable.
1. Direct veneers and other restorative procedures
1. Restoring missing subgingival tooth structure prior to endodontic procedures (this is referred to as the "donut" technique).

Device Description

PermaFlo Flowable Composite

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for a dental product called Permaflo. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device meets specific acceptance criteria.

The letter simply states that the FDA has reviewed the 510(k) notification and determined the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use. This means it has met the regulatory requirements for market clearance, not that its performance was evaluated against specific quantitative acceptance criteria in a clinical study.

Therefore, I cannot provide the requested information based on the content of these documents. The request asks for details about a study evaluating device performance, which is not present in this regulatory clearance letter.

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 consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 1998

Mr. Chester McCoy Regulatory Affairs Manager Ultradent Products, Incorporated 505 W. 10200 South South Jordan, Utah 84095

Re : K974413 Trade Name: Permaflo Regulatory Class: II Product Code: EBF Dated: November 20, 1997 November 24, 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 qeneral 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. 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 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 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 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) 63842041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Timo waki 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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510(k) Number (if known): __Unknown

Device Name: PermaFlo Flowable Composite _____________________________________________________________________________________________________________________________________

Indications For Use:

PermaFlo can be used for:

1. Anterior and posterior restorations, such as Class I, II, III, IV, and V.
1. Luting translucent inlays and onlays. Permalute (chemical cure) is recommended for more opaque or thick inlays/onlays where light cure is not predictable.
1. Direct veneers and other restorative procedures----------------------------------------------------------------------------------------------------------------------------
1. Restoring missing subgingival tooth structure prior to endodontic procedures (this is referred to as the "donut" technique).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number	K974413
Prescription Use	Yes
(Per 21 CFR 801.109)
	OR
	Over-The-Counter Use
	(Optional Format 1-2-96)

Regulation Number and Section

§ 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.