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Ledex Wl-070+

by Dentmate Technology Co., Ltd. 7 variants

Ledex Wl-070+ is a Class II device made by Dentmate Technology Co., Ltd., cleared under FDA 510(k) K163605 on 19 Jan 2017 and listed in FDA GUDID since 16 Jul 2019 (UDI-DI 04719873920679), 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

510(k) K163605

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04719873920679 UDI-DI Date16 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK163605 Date19 Jan 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K163605 decided 19 Jan 2017 Active
  • FDA GUDID UDI-DI 04719873920679 listed 16 Jul 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K163605
  2. Listed FDA GUDID 04719873920679

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ledex
Generic name
Dental/surgical polymerization lamp
Model / reference
WL-070+
Primary DI / UDI-DI
04719873920679
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

Similar devices in this category

Other devices filed under Dental/surgical polymerization lamp.

Other devices from Dentmate Technology Co., Ltd.

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Properties

  • Single use
  • Prescription use
  • Serial number
Other properties (12, all answered No)