The following data is part of a premarket notification filed by Essential Dental Systems, Inc. with the FDA for Endo-express (r) Handpiece.
| Device ID | K111541 |
| 510k Number | K111541 |
| Device Name: | ENDO-EXPRESS (R) HANDPIECE |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | ESSENTIAL DENTAL SYSTEMS, INC. 89 LEUNING STREET SUITE 8 South Hackensack, NJ 07606 |
| Contact | Jeffrey Wan |
| Correspondent | Jeffrey Wan ESSENTIAL DENTAL SYSTEMS, INC. 89 LEUNING STREET SUITE 8 South Hackensack, NJ 07606 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-02 |
| Decision Date | 2012-03-16 |
| Summary: | summary |