The following data is part of a premarket notification filed by Ritter Implants Gmbh & Co. Kg with the FDA for Ritter Dental Implant System.
| Device ID | K160475 |
| 510k Number | K160475 |
| Device Name: | Ritter Dental Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Ritter Implants GmbH & Co. KG gruner Weg 32 Biberach, DE 88400 |
| Contact | Werner Schmitz |
| Correspondent | Raymond Kelly Licensale Inc. 57 Lazy Brook Rd Monroe, CT 06468 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-19 |
| Decision Date | 2016-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| ERITCIODPIT1 | K160475 | 000 |
| ERITCODIT1 | K160475 | 000 |