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GC TEMPRON

by Gc America Inc.

510(k) K935960

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 NumberK935960 Date4 Mar 1994ClearedStatusActive

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  • Withdrawn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
EBG
FDA applicant
GC America, Inc.
Device class
Class II
Regulation
21 CFR Part 872.3770
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

GC TEMPRON is a dental device. It is substantially equivalent to a legally marketed predicate device.

The device was reviewed by the Dental advisory committee and received traditional 510(k) clearance from the FDA. It was manufactured by GC America Inc. in Alsip, Illinois, and the submission was received on December 13, 1993, with a decision date of March 4, 1994.

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Questions

AI-generated answers, 22 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 GC TEMPRON device used for?

    GC TEMPRON is a dental device that was determined to be substantially equivalent to a legally marketed predicate device, meaning it shares the same intended use and technological characteristics as that predicate, though the specific clinical indication is not detailed in the provided data.

  • How was the GC TEMPRON device cleared for market?

    GC TEMPRON received traditional 510(k) clearance from the FDA after being reviewed by the Dental advisory committee, with the submission received on December 13, 1993, and a decision made on March 4, 1994, confirming its substantial equivalence to a predicate device.

  • Who manufactures the GC TEMPRON device and where is it made?

    GC TEMPRON is manufactured by GC America Inc. at their facility located at 3737 W. 127th St., Alsip, Illinois, 60803, United States, as specified in the device’s authorization records.