Contec Light
by Dentaurum
510(k) K030641
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK030641 | Date10 Jun 2003 | StatusActive |
Official records
- FDA 510(k) database K030641
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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, 23 Sep 2026
The Contec Light is an ultraviolet activator used for polymerization in dental applications. It functions as a light-curing device designed to facilitate the hardening of dental materials.
This device is manufactured by Dentaurum and has received FDA 510(k) clearance. It is categorized under dental regulation number 872.6070.
Similar devices
Other devices filed under FDA product code EBZ (Activator, Ultraviolet, For Polymerization).
- CU-75 VISIBLE LIGHT-CURING UNIT by Kab Gloves Unltd.
- PALMLIGHT 10, MODEL 001-00030 by CAO GROUP, INC.
- LED TURBO-PEN by APOZA ENTERPRISE CO., LTD.
- FLASHLITE REBEL* by Discus Dental, Inc.
- BLUEPHASE 16I by Ivoclar Vivadent, Inc.
- D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000 by DXM CO., LTD
- TRANSLUX CL by Kulzer, Inc.
- LED PROLUX 770 by Peng Lim Enterprise Co., Ltd.
- CALSET COMPOSITE HEATER by Addent, Inc.
- 3M AURORA SYSTEM by 3M COMPANY