The following data is part of a premarket notification filed by Dental Savings Club with the FDA for Wolf High Speed Handpieces - Medium Head, Wolf High Speed Handpieces - Small Head.
| Device ID | K160410 |
| 510k Number | K160410 |
| Device Name: | WOlf High Speed Handpieces - Medium Head, WOlf High Speed Handpieces - Small Head |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | Dental Savings Club 31 Serge Garant Montreal, CA H3e 0a6 |
| Contact | Chadi Saade |
| Correspondent | Gordon Wehner QUALMED CORPORATION 23 FORESTVIEW DR. Cambridge, CA N1t1v1 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-16 |
| Decision Date | 2016-09-29 |