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;n-270 Air-motor.
| Device ID | K926154 |
| 510k Number | K926154 |
| Device Name: | HANDPIECE MODELS: MS-350;RS-350;N-270 AIR-MOTOR |
| 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 | 1992-12-07 |
| Decision Date | 1994-03-04 |