The following data is part of a premarket notification filed by Sirona Dental Systems Gmbh with the FDA for Perioscan, Model: D 3496.
| Device ID | K072107 |
| 510k Number | K072107 |
| Device Name: | PERIOSCAN, MODEL: D 3496 |
| Classification | Scaler, Ultrasonic |
| Applicant | SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
| Contact | Fritz Kolle |
| Correspondent | Fritz Kolle SIRONA DENTAL SYSTEMS GMBH FABRIKSTRASSE 31 Bensheim, DE D-64625 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-31 |
| Decision Date | 2008-02-14 |
| Summary: | summary |