LC TEMPORARY FILLING

• K Number: K012360
• Device Name: LC TEMPORARY FILLING
• Manufacturer: PARKELL, INC.
• Date Cleared: 2001-09-06 ( 43 days)
• Product Code: EBG
• Regulation Number: 872.3770
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A light-cured resin intended for use as a temporary restorative material in a tooth prepared to receive an inlay or onlay until such time as the laboratory fabricated final restoration can be inserted into that tooth.

Device Description

A light-cured resin intended for use as a temporary restorative material in a tooth prepared to receive an inlay or onlay until such time as the laboratory fabricated final restoration can be inserted into that tooth.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) summary for a dental temporary filling material, which focuses on regulatory approval and substantial equivalence to existing devices. It does not include details about acceptance criteria, performance studies, or clinical trial methodologies as would be expected for a diagnostic or AI-powered device.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance
2. Sample size used for the test set and data provenance
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results or effect size
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

Summary

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SEP = 6 2001

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K012360

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510(k) SUMMARY

Submitter:	Parkell, Inc.155 Schmitt Blvd.Box 376Farmingdale, NY 11735TEL: [phone]FAX: [phone]
Contact:	Nelson J. Gendusa, DDSDirector of ResearchParkell155 Schmitt Blvd.Box 376Farmingdale, NY 11735
Submission Date:	18 July 2001
Trade Name:	LC Temporary Material
Common Name:	Light Cured Temporary Filling Material
Classification Name:	Temporary Crown & Bridge Resin
Equivalence:	Fermit N, Tempfil F, Tempfil C&B, Tempfil F-2, LC Provifill.
Description/Intended Use:	A light-cured resin intended for use as a temporaryrestorative material in a tooth prepared to receive aninlay or onlay until such time as the laboratory fabricatedfinal restoration can be inserted into that tooth.

PARKELL INC. • 155 Schmitt Blvd., Farmingdale, NY 11735 USA • 631-249-1134 Toll-Frec 1-800-243-7446 • Fax: [phone] • E-Mail: [e-mail]

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure in profile, with three horizontal lines above the head, representing growth and development. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.

Public Health Service

SEP = 6 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nelson J. Gendusa, DDS Director of Research Parkell, Incorporated 155 Schmitt Boulevard P.O. Box 376 Farmingdale, New York 11735

Re: K012360

Trade/Device Name: LC Temporary Filling Regulation Number: 21 CFR 872.3770 Regulation Name: Light-Cured Temporary Filling Materials Regulatory Class: Class II Product Code: EBG Dated: July 18, 2001 Received: July 25, 2001

Dear Dr. Gendusa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Dr. Gendusa

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely,

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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Page ____ of _________________________________________________________________________________________________________________________________________________________________

Ko 2360 510(k Number (if known):_

Device Name: _LC Temporary Filling

Indications for Use: or onlay until such time as the laboratory fabricated final restoration can be inserted into that tooth.

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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K012360

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.