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Litex 680A

by Dentamerica

Litex 680A is a Class II device made by Dentamerica, cleared under FDA 510(k) K955759 on 2 Jan 1996 and listed in FDA GUDID since 5 Oct 2016 (UDI-DI 00858466005172), 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

510(k) K955759

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858466005172 UDI-DI Date5 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK955759 Date2 Jan 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K955759 decided 2 Jan 1996 Active
  • FDA GUDID UDI-DI 00858466005172 listed 5 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K955759
  2. Listed FDA GUDID 00858466005172

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Litex
Generic name
Dental/surgical polymerization lamp
Model / reference
680A
Primary DI / UDI-DI
00858466005172
510(k) Number
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

Other properties (15, all answered No)