The Light 402400

by Gc America Inc. 2 variants

The Light 402400 is a dental/surgical polymerization lamp (FDA Class II; FDA product code EBZ, Activator, Ultraviolet, for Polymerization) made by Gc America Inc., cleared under FDA 510(k) K093751 on 24 Feb 2010 and listed in FDA GUDID since 1 Aug 2016 (UDI-DI D6584024001), 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	NumberD6584024001 UDI-DI	Date1 Aug 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK093751	Date24 Feb 2010Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K093751

Across registries

2 registries list this device

FDA 510(k) K093751 decided 24 Feb 2010 Active
FDA GUDID UDI-DI D6584024001 listed 1 Aug 2016 Listed

Timeline

2 dated events

24 Feb 2010 Cleared FDA 510(k) K093751
1 Aug 2016 Listed FDA GUDID D6584024001

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: The Light
Generic name: Dental/surgical polymerization lamp
Model / Ref / Catalog: 402400

Primary DI / UDI-DI: D6584024001
510(k) Number: K093751
FDA product code: EBZ
GMDN term: Dental/surgical polymerization lamp

Device class: Class II
Regulation number: 872.6070
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Lot / batch number
Expiration date

Other properties (12, all answered No)