The following data is part of a premarket notification filed by Degussa Dental, Inc. with the FDA for Estilux Uv System.
| Device ID | K770113 |
| 510k Number | K770113 |
| Device Name: | ESTILUX UV SYSTEM |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DEGUSSA DENTAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-01-19 |
| Decision Date | 1977-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J014660398680 | K770113 | 000 |