The following data is part of a premarket notification filed by Dabi-atlante America Corp. with the FDA for Ca And St.
Device ID | K926155 |
510k Number | K926155 |
Device Name: | CA AND ST |
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 |