The following data is part of a premarket notification filed by Promident Llc with the FDA for Challenger/classic Push Button Handpiece.
| Device ID | K080240 |
| 510k Number | K080240 |
| Device Name: | CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | PROMIDENT LLC 242 NORTH MAIN ST. New City, NY 10956 |
| Contact | Gary Kris |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-01-31 |
| Decision Date | 2008-02-07 |