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TRC-Paste

by Km Corporation

510(k) K133716

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK133716 Date9 Apr 2014ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KIF
Device Class
Class II
Regulation
21 CFR Part 872.3820
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

TRC-Paste is a resin root canal filling device. It is classified as a dental device intended for use in endodontic procedures.

This device is regulated as a Class 2 medical device under FDA 510(k) clearance K133716. It is manufactured by Km Corporation and was cleared through the traditional 510(k) pathway.

Other devices from Km Corp.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of TRC-Paste?

    TRC-Paste is a resin-based medical device specifically designed for use as a root canal filling material during endodontic procedures.

  • What is the regulatory status of this device?

    TRC-Paste is a Class 2 medical device that has received FDA 510(k) clearance under the number K133716, following a traditional 510(k) submission pathway.

  • Who is the manufacturer of TRC-Paste?

    The device is manufactured by Km Corporation, which is based in Anaheim, California.