EXA Advanced 137119

by Gc America Inc.

EXA Advanced 137119 is a Class II device made by Gc America Inc., cleared under FDA 510(k) K955932 on 11 Mar 1996 and listed in FDA GUDID since 12 Aug 2022 (UDI-DI 10386040013345), 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	Number10386040013345 UDI-DI	Date12 Aug 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK955932	Date11 Mar 1996Decided	StatusActive

Official records

AccessGUDID record UDI-DI 10386040013345
FDA 510(k) database 510(k) number K955932

Across registries

2 registries list this device

FDA 510(k) K955932 decided 11 Mar 1996 Active
FDA GUDID UDI-DI 10386040013345 listed 12 Aug 2022 Listed

Timeline

2 dated events

11 Mar 1996 Cleared FDA 510(k) K955932
12 Aug 2022 Listed FDA GUDID 10386040013345

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: EXA Advanced
Generic name: Silicone dental impression material
Model / Ref / Catalog: 137119

Primary DI / UDI-DI: 10386040013345
510(k) Number: K955932
FDA product code: ELW
GMDN term: Silicone dental impression material

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

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)