The following data is part of a premarket notification filed by Dabi-atlante America Corp. with the FDA for Handpiece Models Ms-350, Rs-350; Air Motor N-270.
| Device ID | K922437 |
| 510k Number | K922437 |
| Device Name: | HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-270 |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | DABI-ATLANTE AMERICA CORP. 5453 WEST WATERS AVE. STE. 200 Tampa, FL 33634 |
| Contact | Ubiraci R Fernandes |
| Correspondent | Ubiraci R Fernandes DABI-ATLANTE AMERICA CORP. 5453 WEST WATERS AVE. STE. 200 Tampa, FL 33634 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-22 |
| Decision Date | 1992-12-21 |