The following data is part of a premarket notification filed by Dentamax, Inc. with the FDA for Acetal Dental/preformed Clasp.
| Device ID | K983558 |
| 510k Number | K983558 |
| Device Name: | ACETAL DENTAL/PREFORMED CLASP |
| Classification | Clasp, Preformed |
| Applicant | DENTAMAX, INC. 4311 S.W. RESEARCH WAY Corvallis, OR 97333 |
| Contact | Martin A Rigutto |
| Correspondent | Martin A Rigutto DENTAMAX, INC. 4311 S.W. RESEARCH WAY Corvallis, OR 97333 |
| Product Code | EHP |
| CFR Regulation Number | 872.3285 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-13 |
| Decision Date | 1999-01-07 |