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Exa Bite Registration Material

by Gc America Inc.

510(k) K933206

Exa Bite Registration Material is a Class II device made by Gc America Inc., cleared under FDA 510(k) K933206 on 29 Sep 1993, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK933206 Date29 Sep 1993ClearedStatusActive

Official records

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  • Withdrawn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
ELW
FDA applicant
GC America, Inc.
Device class
Class II
Regulation
21 CFR Part 872.3660
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Devices cleared under K933206

6 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K933206
UDI-DISize and differences
EXABITE™ 132412
Gc America Inc.
132412 / 13241210386040004961 —On the market
EXABITE™ 132412
Gc America Inc.
132412 / 132412D6581324121 —On the market
EXABITE™ 132418
Gc America Inc.
132418 / 13241810386040004978 —On the market
EXABITE™ 132418
Gc America Inc.
132418 / 132418D6581324181 —On the market
EXACLEAR 008482
Gc America Inc.
008482 / 008482D0470084821
Total Volume 48 mL
On the market
EXACLEAR 008482
Gc America Inc.
008482 / 00848214548161333740
Total Volume 48 mL
On the market

Similar devices

Other devices filed under FDA product code ELW (Material, Impression).

Other devices from Gc America Inc.

See all devices from Gc America Inc. →