The following data is part of a premarket notification filed by Mdt Corp., Inc. with the FDA for Odontoson 3.
Device ID | K782133 |
510k Number | K782133 |
Device Name: | ODONTOSON 3 |
Classification | Scaler, Ultrasonic |
Applicant | MDT CORP., 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 | 1978-12-27 |
Decision Date | 1979-02-27 |