The following data is part of a premarket notification filed by Roydent Dental Products, Inc. with the FDA for Mucopren Soft Relining System.
| Device ID | K983357 |
| 510k Number | K983357 |
| Device Name: | MUCOPREN SOFT RELINING SYSTEM |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-24 |
| Decision Date | 1998-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E217281061 | K983357 | 000 |
| E217281051 | K983357 | 000 |
| E217156871 | K983357 | 000 |
| E217156861 | K983357 | 000 |
| E217142031 | K983357 | 000 |