The following data is part of a premarket notification filed by Safari Dental, Inc. with the FDA for Dentacenter/expedition, Model Saf-430.
| Device ID | K100212 |
| 510k Number | K100212 |
| Device Name: | DENTACENTER/EXPEDITION, MODEL SAF-430 |
| Classification | Unit, Operative Dental |
| Applicant | SAFARI DENTAL, INC. 94 D ENTERPRISES BOUL. Boisbriand, Quebec, CA J7g 2t3 |
| Contact | Andre Mathieu |
| Correspondent | Andre Mathieu SAFARI DENTAL, INC. 94 D ENTERPRISES BOUL. Boisbriand, Quebec, CA J7g 2t3 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-25 |
| Decision Date | 2010-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D104SAF60646 | K100212 | 000 |
| D104SAF430 | K100212 | 000 |
| D104SAF4302XP0 | K100212 | 000 |
| D104SAF433XP0 | K100212 | 000 |
| D104SAF470 | K100212 | 000 |
| D104SAF500CART0 | K100212 | 000 |
| D104SAF500M2 | K100212 | 000 |
| D104SAF500M4 | K100212 | 000 |
| D104SAF531SERIES2 | K100212 | 000 |
| D104SAF60626 | K100212 | 000 |
| D104SAF4302 | K100212 | 000 |