Optiglaze™ 008411

by Gc America Inc.

Optiglaze™ 008411 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K133836 on 6 Mar 2014 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D0470084111), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberD0470084111 UDI-DI	Date1 Aug 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK133836	Date6 Mar 2014Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K133836

Across registries

2 registries list this device

FDA 510(k) K133836 decided 6 Mar 2014 Active
FDA GUDID UDI-DI D0470084111 listed 1 Aug 2016 Listed

Timeline

2 dated events

6 Mar 2014 Cleared FDA 510(k) K133836
1 Aug 2016 Listed FDA GUDID D0470084111

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Optiglaze™
Generic name: Dental unfilled resin sealant/coating
Model / Ref / Catalog: 008411

Primary DI / UDI-DI: D0470084111
510(k) Number: K133836
FDA product code: EBD
GMDN term: Dental unfilled resin sealant/coating

Device class: Class II
Regulation number: 872.3310
GUDID distribution status: In Commercial Distribution

Size: Total Volume — 2.6 Milliliter

Similar devices in this category

Other devices filed under Dental unfilled resin sealant/coating.

Other devices from Gc America Inc.

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Properties

Prescription use
Lot / batch number
Expiration date

Other properties (12, all answered No)