The following data is part of a premarket notification filed by Dentamax, Inc. with the FDA for The.r.mo.free.
| Device ID | K990448 |
| 510k Number | K990448 |
| Device Name: | THE.R.MO.FREE |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-12 |
| Decision Date | 1999-03-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THE.R.MO.FREE 75719618 2418802 Dead/Cancelled |
Pressing North America Inc. 1999-06-02 |