The following data is part of a premarket notification filed by Discus Dental, Llc with the FDA for Insight Ultrasonic Inserts.
| Device ID | K092417 |
| 510k Number | K092417 |
| Device Name: | INSIGHT ULTRASONIC INSERTS |
| Classification | Scaler, Ultrasonic |
| Applicant | DISCUS DENTAL, LLC 8550 HIGUERA ST. Culver City, CA 90232 |
| Contact | Winkie Wong |
| Correspondent | Winkie Wong DISCUS DENTAL, LLC 8550 HIGUERA ST. Culver City, CA 90232 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-07 |
| Decision Date | 2009-12-11 |
| Summary: | summary |