The following data is part of a premarket notification filed by Bionexus, Inc. with the FDA for Nexadent (dental Cement).
| Device ID | K870209 |
| 510k Number | K870209 |
| Device Name: | NEXADENT (DENTAL CEMENT) |
| Classification | Cement, Dental |
| Applicant | BIONEXUS, INC. 5257 N. BLVD. P.O. DRAWER 58517 Raleigh, NC 27658 |
| Contact | Charles R Desmet |
| Correspondent | Charles R Desmet BIONEXUS, INC. 5257 N. BLVD. P.O. DRAWER 58517 Raleigh, NC 27658 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-20 |
| Decision Date | 1987-02-19 |