The following data is part of a premarket notification filed by Scholly Fiberoptic Gmbh with the FDA for Scican Classic.
| Device ID | K984556 |
| 510k Number | K984556 |
| Device Name: | SCICAN CLASSIC |
| Classification | Unit, Operative Dental |
| Applicant | SCHOLLY FIBEROPTIC GMBH ROBERT-BOSCH-STR. 1-3 Denzlingen, DE D-79211 |
| Contact | Carsten Schlenker |
| Correspondent | Carsten Schlenker SCHOLLY FIBEROPTIC GMBH ROBERT-BOSCH-STR. 1-3 Denzlingen, DE D-79211 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-23 |
| Decision Date | 1999-02-09 |
| Summary: | summary |