The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec/w&h Electric Handpiece Motor.
| Device ID | K133776 |
| 510k Number | K133776 |
| Device Name: | A-DEC/W&H ELECTRIC HANDPIECE MOTOR |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | A-DEC, INC. 2601 CRESTVIEW AVE. Newberg, OR 97132 |
| Contact | Bonnie Dundas |
| Correspondent | Bonnie Dundas A-DEC, INC. 2601 CRESTVIEW AVE. Newberg, OR 97132 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-12 |
| Decision Date | 2014-05-28 |
| Summary: | summary |