The following data is part of a premarket notification filed by Redent-nova Ltd. with the FDA for Saf (self Adjusting File).
| Device ID | K092933 |
| 510k Number | K092933 |
| Device Name: | SAF (SELF ADJUSTING FILE) |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | REDENT-NOVA LTD. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan REDENT-NOVA LTD. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-23 |
| Decision Date | 2010-01-14 |
| Summary: | summary |