The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec/w&h Profin Reciprocating Contra-angle Handpiece Attachment.
| Device ID | K082827 |
| 510k Number | K082827 |
| Device Name: | A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
| Contact | Thomas H Louisell |
| Correspondent | Thomas H Louisell A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-25 |
| Decision Date | 2009-01-07 |