The following data is part of a premarket notification filed by D.b.i. America Corp. with the FDA for Mrs-400, Maxi 400, Mrsl-400, Maxi 400l.
| Device ID | K981990 |
| 510k Number | K981990 |
| Device Name: | MRS-400, MAXI 400, MRSL-400, MAXI 400L |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | D.B.I. AMERICA CORP. 8194 WOODLAND CENTER BLVD. Tampa, FL 33614 |
| Contact | Ubiraci R Fernandes |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1998-06-08 |
| Decision Date | 1998-06-22 |