The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for W&h Roto Quick Couplings.
| Device ID | K945734 |
| 510k Number | K945734 |
| Device Name: | W&H ROTO QUICK COUPLINGS |
| 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 | 1994-11-23 |
| Decision Date | 1995-10-05 |