The following data is part of a premarket notification filed by Sophos Technologic with the FDA for Sophos Dental Diamond.
| Device ID | K943841 |
| 510k Number | K943841 |
| Device Name: | SOPHOS DENTAL DIAMOND |
| Classification | Instrument, Diamond, Dental |
| Applicant | SOPHOS TECHNOLOGIC 2802 RIACHUELO CIRCLE San Clemente, CA 92673 |
| Contact | Daniel W Loyer |
| Correspondent | Daniel W Loyer SOPHOS TECHNOLOGIC 2802 RIACHUELO CIRCLE San Clemente, CA 92673 |
| Product Code | DZP |
| CFR Regulation Number | 872.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-05 |
| Decision Date | 1994-09-16 |