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CL-DC20, CL-DC21

by Good Doctors Co., Ltd.

510(k) K093751

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093751 Date24 Feb 2010ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EBZ
Device class
Class II
Regulation
21 CFR Part 872.6070
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a dental curing light, specifically the CL-DC20 and CL-DC21 models, designed for the polymerization of dental composites using visible light. It is classified as a Class II medical device under FDA regulation number 872.6070 and has received traditional 510(k) clearance as substantially equivalent to a predicate device.

The device is supplied as a reusable handpiece unit with dimensions of 232 x 40 x 26 mm and a weight of 107 g (including battery). It operates with selectable curing modes, light intensity, and time settings, and is intended for use in dental clinical settings. Storage and handling should follow the manufacturer's instructions as detailed in the user manual.

Devices cleared under K093751

8 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K093751
UDI-DISize and differences
Battery_Drs Light Claver CL0200110
GOOD DOCTORS CO., LTD.
CL020011008800025400210
Prescription: no
On the market
Charger_Drs Light Claver DC020M1001
GOOD DOCTORS CO., LTD.
DC020M100108800025400203
Prescription: no
On the market
Drs Light Claver CL-DC20
GOOD DOCTORS CO., LTD.
CL-DC2008800025400081
Prescription: no
On the market
Guide-cap_Drs Light Claver CL0200210
GOOD DOCTORS CO., LTD.
CL020021008800025400227
Prescription: no
On the market
The Light 402400
Gc America Inc.
402400 / 40240010386040012478
Prescription: yes
On the market
The Light 402400
Gc America Inc.
402400 / 402400D6584024001
Prescription: yes
On the market
The Light 405 402405
Gc America Inc.
402405 / 40240510386040012485
Prescription: yes
On the market
The Light 405 402405
Gc America Inc.
402405 / 402405D6584024051
Prescription: yes
On the market

Similar devices

Other devices filed under FDA product code EBZ (Activator, Ultraviolet, For Polymerization).

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