Equia® 452015

by Gc America Inc. 2 variants

Equia® 452015 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K091106 on 17 Jun 2009 and listed in FDA GUDID since 13 Jul 2022 (UDI-DI 10386040010610), active as of 23 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 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10386040010610 UDI-DI	Date13 Jul 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK091106	Date17 Jun 2009Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10386040010610
FDA 510(k) database 510(k) number K091106

Across registries

2 registries list this device

FDA 510(k) K091106 decided 17 Jun 2009 Active
FDA GUDID UDI-DI 10386040010610 listed 13 Jul 2022 Listed

Timeline

2 dated events

17 Jun 2009 Cleared FDA 510(k) K091106
13 Jul 2022 Listed FDA GUDID 10386040010610

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Equia®
Generic name: Glass ionomer dental cement
Model / Ref / Catalog: 452015

Primary DI / UDI-DI: 10386040010610
510(k) Number: K091106
FDA product code: EMA
GMDN term: Glass ionomer dental cement

Device class: Class II
Regulation number: 872.3275
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Glass ionomer dental cement.

Other devices from Gc America Inc.

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Properties

Single use
Prescription use
Lot / batch number
Expiration date

Other properties (11, all answered No)