The following data is part of a premarket notification filed by Essential Dental Systems, Inc. with the FDA for Eds Ultrasonic Tips.
| Device ID | K132609 |
| 510k Number | K132609 |
| Device Name: | EDS ULTRASONIC TIPS |
| Classification | Scaler, Ultrasonic |
| 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 | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-20 |
| Decision Date | 2014-01-22 |
| Summary: | summary |