РкомРт® L-Pop® is classified as a Resin Tooth Bonding Agent (21 C.F.R. § 872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer restorative material). PROMP® L-POP® is similar and substantially equivalent in intended use, composition, and function to ESPE'S compomer bonding material HYTAC® OSB. The filler of PROMPT® L-POP® is contained in Zhermack's alginate based impression material HYDROGUM®. ESPE's composite luting cement COMPOLUTE® contains the same photo initiator.

AI/ML Overview

The provided text is a 510(k) summary for a dental device, PROMPT® L-POP®. It outlines the device description, classification, and substantial equivalence to predicate devices. However, it does not include any information about acceptance criteria, analytical or clinical studies, performance data, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is absent from the provided text.

Specifically, the following information cannot be extracted:

A table of acceptance criteria and the reported device performance: Not present. The document only mentions predicate devices are "well established and determined to be safe and effective," but provides no specific criteria or performance data for PROMPT® L-POP®.
Sample sizes used for the test set and the data provenance: Not present. No study details are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No study details are provided.
Adjudication method for the test set: Not present. No study details are provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present. No study details are provided.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not present. This device is a component (bonding agent), not an algorithm.
The type of ground truth used: Not present. No study details are provided.
The sample size for the training set: Not present. No study details are provided.
How the ground truth for the training set was established: Not present. No study details are provided.

The document is a regulatory submission focusing on the device's substantial equivalence to previously approved devices based on its intended use, composition, and function, rather than presenting a detailed performance study with acceptance criteria.

Summary

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K984244

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ll.

Submitter

Name:	ESPE Dental AG
Street:	ESPE Platz
ZIP-Code, City:	D-82229 Seefeld
Federal State:	Bavaria
Country:	Germany
Contact:	Dr. Andreas Petermann, Regulatory Affairs
Phone:	011-49-8152-700395
Fax:	011-49-8152-700869
E-mail	Andreas_Petermann@ESPE.de
Date:	11/17/1998

Name of Device

Proprietary Name:	PROMPT® L-POP®
Classification Name:	Resin Tooth Bonding Agent
Common Name:	Compomer Bonding Agent

Predicate Devices

HYTAC® OSB by ESPE..................................(K962442)
HYDROGUM® by Zhermack.....................(K935898)
COMPOLUTE® by ESPE........................(K974458)

Description for the Premarket Notification

PROMP® L-POP® is similar and substantially equivalent in intended use, composition, and function to ESPE'S compomer bonding material HYTAC® OSB. The filler of PROMPT® L-POP® is contained in Zhermack's alginate based impression material HYDROGUM®. ESPE's composite luting cement COMPOLUTE®

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contains the same photo initiator. All above mentioned predicate devices are well established and determined to be safe and effective.

ﺮ

510(k) PROMPT® L-POP®

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 8 1999

Dr. Andreas Petermann Requlatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld Bavaria, Germany

Re : K984246 Prompt® L-Pop® Trade Name: Regulatory Class: II Product Code: KLE Dated: November 17, 1998 November 27, 1998 Received:

Dear Dr. 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 legally marketed predicate 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 of the Act. The general controls provisions 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. ਰੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements action. 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 - Dr. Petermann

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 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 premarket notification" (21CFR 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/dsma/dsmamajp.html." .

Sincerely yours,

Timothy A. Ulatowski

Timothy 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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STATEMENT OF INDICATIONS FOR USE

Device Name:

PROMPT® L-POP®

Indications for use:

. Bonding of Enamel/Dentin and Compomer Restorative Materials

Susan Ruaser

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number

Prescription use: 因

Over-the counter use □

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.