The following data is part of a premarket notification filed by Fibra Sonics, Inc. with the FDA for Hygientist; Cycloson I & Ii; Retrofit.
| Device ID | K812909 |
| 510k Number | K812909 |
| Device Name: | HYGIENTIST; CYCLOSON I & II; RETROFIT |
| Classification | Scaler, Ultrasonic |
| Applicant | FIBRA SONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-19 |
| Decision Date | 1981-12-14 |