Identifiers
- 510(k) Number
- K030641 FDA 510(k)
- FDA Product Code
- EBZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6070 FDA 510(k)
- Regulation Number
- 872.6070 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Frequently asked questions
What is the primary function of the Contec Light?
The Contec Light is an ultraviolet activator used specifically for polymerization in dental applications. It is designed to facilitate the hardening process of various dental materials.
Who is the manufacturer of this device?
The Contec Light is manufactured by Dentaurum, based in Newtown, Pennsylvania.
Has this device received regulatory clearance?
Yes, the Contec Light has received FDA 510(k) clearance. It is categorized under dental regulation number 872.6070.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030641 | Class II | Active |
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Manufacturer
- Manufacturer
- Dentaurum
Sources (1)
- FDA 510(k) K030641 24 fields · synced Sep 23, 2026