The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for Elcacam.
| Device ID | K032070 |
| 510k Number | K032070 |
| Device Name: | ELCACAM |
| Classification | Unit, Operative Dental |
| Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
| Contact | Tom Louisell |
| Correspondent | Tom Louisell 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 | 2003-07-03 |
| Decision Date | 2003-08-27 |