EXAlence™ 137004

by Gc America Inc. 2 variants

EXAlence™ 137004 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K041398 on 25 Jun 2004 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D6581370041), 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	NumberD6581370041 UDI-DI	Date1 Aug 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK041398	Date25 Jun 2004Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K041398

Across registries

2 registries list this device

FDA 510(k) K041398 decided 25 Jun 2004 Active
FDA GUDID UDI-DI D6581370041 listed 1 Aug 2016 Listed

Timeline

2 dated events

25 Jun 2004 Cleared FDA 510(k) K041398
1 Aug 2016 Listed FDA GUDID D6581370041

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: EXAlence™
Generic name: Silicone dental impression material
Model / Ref / Catalog: 137004

Primary DI / UDI-DI: D6581370041
510(k) Number: K041398
FDA product code: ELW
GMDN term: Silicone dental impression material

Device class: Class II
Regulation number: 872.3660
GUDID distribution status: In Commercial Distribution

Size: Total Volume — 48 Milliliter

Similar devices in this category

Other devices filed under Silicone dental impression material.

Other devices from Gc America Inc.

See all devices from Gc America Inc. →

Properties

Prescription use
Lot / batch number
Expiration date

Other properties (12, all answered No)