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Optiglaze™ 008411

by Gc America Inc.

Part of a family of 18 devices: see the family page

Ref 008411

Optiglaze™ 008411 is a device classified as Class IIa in the EU and Class II in the US made by Gc America Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI ++J022MD0037K9), cleared under FDA 510(k) K133836 on 6 Mar 2014 and listed in FDA GUDID since 5 Aug 2022 (UDI-DI 14548161292047), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K133836

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++J022MD0037K9 Basic UDI-DI 14548161292047UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14548161292047 UDI-DI Date5 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK133836 Date6 Mar 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++J022MD0037K9 registered 22 Oct 2026 Active
  • FDA 510(k) K133836 decided 6 Mar 2014 Active
  • FDA GUDID UDI-DI 14548161292047 listed 5 Aug 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K133836
  2. Listed FDA GUDID 14548161292047
  3. Registered EUDAMED ++J022MD0037K9

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
OPTIGLAZE™ color EUDAMED
Optiglaze™ GUDID
Generic name
Dental unfilled resin sealant/coating
Model / Ref / Catalog
008411
Primary DI / UDI-DI
14548161292047
Basic UDI-DI
++J022MD0037K9
Direct marketing DI
14548161383868
510(k) Number
FDA product code
EBD
EMDN code
Q01010403 Dental abrasive and polishing materials
GMDN term
Dental unfilled resin sealant/coating
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3310
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 2.6 Milliliter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental unfilled resin sealant/coating

Cleared under the same submission (K133836)

and 8 more cleared under K133836

Similar devices in this category

Other devices filed under DENTAL ABRASIVE AND POLISHING MATERIALS.

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)