The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec 3131 Duo Wallmount (with Instrumentation).
| Device ID | K933165 |
| 510k Number | K933165 |
| Device Name: | A-DEC 3131 DUO WALLMOUNT (WITH INSTRUMENTATION) |
| Classification | Unit, Operative 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 | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-29 |
| Decision Date | 1993-10-12 |