The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for W&h 798 Top Air Turbine Triple Spray.
Device ID | K944717 |
510k Number | K944717 |
Device Name: | W&H 798 TOP AIR TURBINE TRIPLE SPRAY |
Classification | Handpiece, Air-powered, Dental |
Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
Contact | Patrick Ridenour |
Correspondent | Patrick Ridenour A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-23 |
Decision Date | 1995-06-02 |