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Optiglaze Color

by Gc America Inc.

510(k) K133836

Optiglaze Color is a Class II device made by Gc America Inc., cleared under FDA 510(k) K133836 on 6 Mar 2014, 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 NumberK133836 Date6 Mar 2014ClearedStatusActive

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  • Withdrawn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
EBD
FDA applicant
GC America, Inc.
Device class
Class II
Regulation
21 CFR Part 872.3310
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K133836

38 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 K133836
UDI-DISize and differences
OPTIGLAZE™ 002613
Gc America Inc.
002613 / 00261314548161282574
Total Volume 15 mL
On the market
OPTIGLAZE™ 002613
Gc America Inc.
002613 / 002613D0470026131
Total Volume 15 mL
On the market
OPTIGLAZE™ 008408
Gc America Inc.
008408 / 008408D0470084081
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008408
Gc America Inc.
008408 / 00840814548161282765
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008409
Gc America Inc.
008409 / 008409D0470084091
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008409
Gc America Inc.
008409 / 00840914548161283298
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008410
Gc America Inc.
008410 / 00841014548161292030
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008410
Gc America Inc.
008410 / 008410D0470084101
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008411
Gc America Inc.
008411 / 00841114548161292047
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008411
Gc America Inc.
008411 / 008411D0470084111
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008412
Gc America Inc.
008412 / 00841214548161292054
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008412
Gc America Inc.
008412 / 008412D0470084121
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008413
Gc America Inc.
008413 / 008413D0470084131
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008413
Gc America Inc.
008413 / 00841314548161283335
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008414
Gc America Inc.
008414 / 00841414548161292061
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008414
Gc America Inc.
008414 / 008414D0470084141
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008415
Gc America Inc.
008415 / 00841514548161283342
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008415
Gc America Inc.
008415 / 008415D0470084151
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008416
Gc America Inc.
008416 / 00841614548161292078
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008416
Gc America Inc.
008416 / 008416D0470084161
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008417
Gc America Inc.
008417 / 008417D0470084171
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008417
Gc America Inc.
008417 / 00841714548161283359
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008418
Gc America Inc.
008418 / 008418D0470084181
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008418
Gc America Inc.
008418 / 00841814548161292085
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008419
Gc America Inc.
008419 / 008419D0470084191
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008419
Gc America Inc.
008419 / 00841914548161283328
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008420
Gc America Inc.
008420 / 00842014548161283304
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008420
Gc America Inc.
008420 / 008420D0470084201
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008421
Gc America Inc.
008421 / 008421D0470084211
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008421
Gc America Inc.
008421 / 00842114548161292092
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008422
Gc America Inc.
008422 / 008422D0470084221
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008422
Gc America Inc.
008422 / 00842214548161292108
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008423
Gc America Inc.
008423 / 00842314548161292115
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008423
Gc America Inc.
008423 / 008423D0470084231
Total Volume 2.6 mL
On the market
OPTIGLAZE™ 008424
Gc America Inc.
008424 / 008424D0470084241
Total Volume 5 mL
On the market
OPTIGLAZE™ 008424
Gc America Inc.
008424 / 00842414548161283311
Total Volume 5 mL
On the market
OPTIGLAZE™ 008425
Gc America Inc.
008425 / 00842514548161292122
Total Volume 5 mL
On the market
OPTIGLAZE™ 008425
Gc America Inc.
008425 / 008425D0470084251
Total Volume 5 mL
On the market

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