The following data is part of a premarket notification filed by Dentamerica with the FDA for Endomax Cordless Endodontic Handpiece.
| Device ID | K092833 |
| 510k Number | K092833 |
| Device Name: | ENDOMAX CORDLESS ENDODONTIC HANDPIECE |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | DENTAMERICA 18688 E SAN JOSE AVE Industry, CA 91748 |
| Contact | Eric Huang |
| Correspondent | Eric Huang DENTAMERICA 18688 E SAN JOSE AVE Industry, CA 91748 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-15 |
| Decision Date | 2010-01-07 |
| Summary: | summary |