The following data is part of a premarket notification filed by Dentalez Group, Stardental Division with the FDA for Nutorque Programmable Electric System.
| Device ID | K083252 |
| 510k Number | K083252 |
| Device Name: | NUTORQUE PROGRAMMABLE ELECTRIC SYSTEM |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | DENTALEZ GROUP, STARDENTAL DIVISION 1816 COLONIAL VILLAGE LN. Lancaster, PA 17601 |
| Contact | Dale Braas |
| Correspondent | J.a. Van Vugt DEKRA CERTIFICATION B.V. UTRECHTSEWEG 310 Arnhem, NL Nl-6812 Ar |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-11-04 |
| Decision Date | 2009-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7022652020 | K083252 | 000 |