The following data is part of a premarket notification filed by Discus Dental Inc. with the FDA for Protege Ultrasonic Insert.
| Device ID | K051776 |
| 510k Number | K051776 |
| Device Name: | PROTEGE ULTRASONIC INSERT |
| Classification | Scaler, Ultrasonic |
| Applicant | DISCUS DENTAL INC. 8550 HIGUERA ST. Culver City, CA 90232 |
| Contact | Suzanne Ridgway |
| Correspondent | Alfredo J Quattrone CALIFORNIA DEPARTMENT OF HEALTH SERVICES P.O. BOX 997 413 FDB MAILSTOP 7602 Sacramento, CA 95899 -7413 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-07-01 |
| Decision Date | 2005-07-13 |