The following data is part of a premarket notification filed by Sopro with the FDA for S555 Intraoral Dental Camera.
| Device ID | K983625 |
| 510k Number | K983625 |
| Device Name: | S555 INTRAORAL DENTAL CAMERA |
| Classification | Unit, Operative Dental |
| Applicant | SOPRO PLACE ST. CHRISTOPHE LES ACCATES-LA VALENTINE Marseille, FR 13011 |
| Contact | Pierre Montillot |
| Correspondent | Pierre Montillot SOPRO PLACE ST. CHRISTOPHE LES ACCATES-LA VALENTINE Marseille, FR 13011 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-15 |
| Decision Date | 1999-01-11 |
| Summary: | summary |