The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Proof Alginate Impression Material.
| Device ID | K854855 |
| 510k Number | K854855 |
| Device Name: | PROOF ALGINATE IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | SYBRON CORP. P.O. BOX 455 28200 WICK ROAD Romulus, MI 48174 |
| Contact | Benjamin Weaver |
| Correspondent | Benjamin Weaver SYBRON CORP. P.O. BOX 455 28200 WICK ROAD Romulus, MI 48174 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-05 |
| Decision Date | 1986-01-30 |