The following data is part of a premarket notification filed by Roydent Dental Products, Inc. with the FDA for Panasil Impression Material.
| Device ID | K954281 |
| 510k Number | K954281 |
| Device Name: | PANASIL IMPRESSION MATERIAL |
| Classification | Material, Impression |
| Applicant | ROYDENT DENTAL PRODUCTS, INC. 1010 WEST HAMLIN RD. Rochester Hills, MI 48309 |
| Contact | Don Leroy |
| Correspondent | Don Leroy ROYDENT DENTAL PRODUCTS, INC. 1010 WEST HAMLIN RD. Rochester Hills, MI 48309 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-13 |
| Decision Date | 1996-06-24 |