The following data is part of a premarket notification filed by Redent Nova Ltd with the FDA for Rdt3 Handpiece Head Model Rdt3.
| Device ID | K101172 |
| 510k Number | K101172 |
| Device Name: | RDT3 HANDPIECE HEAD MODEL RDT3 |
| Classification | Handpiece, Belt And/or Gear Driven, Dental |
| Applicant | REDENT NOVA LTD COLUMBIA SQUARE 555 13TH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan REDENT NOVA LTD COLUMBIA SQUARE 555 13TH STREET, NW Washington, DC 20004 |
| Product Code | EFA |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-26 |
| Decision Date | 2010-07-27 |
| Summary: | summary |