Fiberfill SGP is a root canal filling thermal plastic composite material used for endodontic therapy to fill the root canal of a tooth in replacing conventional Gutta Percha material.

Device Description

Fiberfill SGP is a root canal filling thermal plastic composite material.

AI/ML Overview

This document is an FDA letter regarding the clearance of a medical device, Fiberfill™ SGP, as substantially equivalent to a predicate device. It does not contain information about acceptance criteria, device performance, or any studies using AI. The letter is a regulatory approval document and not a scientific study report.

Therefore, I cannot provide the requested information based on the provided text. The document does not include:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for a test set.
Number or qualifications of experts for ground truth.
Adjudication method.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study or AI assistance.
Results of a standalone algorithm study.
Type of ground truth used in a study.
Sample size for a training set.
How ground truth for a training set was established.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of an eagle with three lines forming its body and head. The text reads, "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2003

Ms. Annmarie Tenero Paralegal Pentron Laboratory Technologies, LLC 53 North Plains Industrial Road P.O. Box 724 Wallingford, Connecticut 06492-0724

Re: K023819

Trade/Device Name: Fiberfill™ SGP Regulation Number: 21 CFR 872.3850 Regulation Name: Gutta Percha Regulatory Class: I Product Codes: EKM Dated: March 7, 2003 Received: March 7, 2003

Dear Ms. Tenero:

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.

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Page 2 - Ms. Annmarie Tenero

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.

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), please contact the Office of Compliance at (301) 594-4613. 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 Part 807.97) you may obtain. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Susan Romney

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5.0 INDICATION FOR USE STATEMENT

510(k) NUMBER (IF KNOWN):

DEVICE NAME: Fiberfill SGP

INDICATION FOR USE:

Fiberfill SGP is a root canal filling thermal plastic composite material used for endodontic therapy to fill the root canal of a tooth in replacing conventional Gutta Percha material.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over -The-Counter-Use (Optional Format 1-2-96) 5.0

Rai Morley for MSR

(Division Sign-O Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

Pentron Clinical Technologies, LLC. 510K Submission - Fiberfill SGP

Regulation Number and Section

§ 872.3850 Gutta percha.

(a)
Identification. Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.