The following data is part of a premarket notification filed by Dentamerica with the FDA for Litex 680.
| Device ID | K955759 |
| 510k Number | K955759 |
| Device Name: | LITEX 680 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | DENTAMERICA 18320 BEDFORD CIRCLE P.O. BOX 3200 Industry, CA 91744 |
| Contact | J. Huang |
| Correspondent | J. Huang DENTAMERICA 18320 BEDFORD CIRCLE P.O. BOX 3200 Industry, CA 91744 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-18 |
| Decision Date | 1996-01-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858466005226 | K955759 | 000 |
| 00858466005202 | K955759 | 000 |
| 00858466005196 | K955759 | 000 |
| 00858466005189 | K955759 | 000 |
| 00858466005172 | K955759 | 000 |