The following data is part of a premarket notification filed by Ritter Concept Gmbh with the FDA for Vanguard Dental Unit.
| Device ID | K161734 |
| 510k Number | K161734 |
| Device Name: | Vanguard Dental Unit |
| Classification | Unit, Operative Dental |
| Applicant | RITTER CONCEPT GMBH BAHNHOFSTRABE 65 Zwonitz, DE 208297 |
| Contact | Wen Fang |
| Correspondent | Raymond Kelly LICENSALE INC 57 LAZY BROOK RD Monroe, CT 06468 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-23 |
| Decision Date | 2016-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| ERICVSP000110 | K161734 | 000 |
| ERICVS0000110 | K161734 | 000 |
| ERICVP0000110 | K161734 | 000 |
| ERICV00000110 | K161734 | 000 |