The following data is part of a premarket notification filed by Columbia Scientific, Inc. with the FDA for 3d/dental.
| Device ID | K885322 |
| 510k Number | K885322 |
| Device Name: | 3D/DENTAL |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | COLUMBIA SCIENTIFIC, INC. 8940-K OLD ANNAPOLIS RD. Columbia, MD 21045 |
| Contact | Charles Stockham |
| Correspondent | Charles Stockham COLUMBIA SCIENTIFIC, INC. 8940-K OLD ANNAPOLIS RD. Columbia, MD 21045 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-28 |
| Decision Date | 1989-02-09 |