The following data is part of a premarket notification filed by Micro Motors, Inc. with the FDA for Dynasonic Plaque Remover & Polisher Dynatip.
Device ID | K903298 |
510k Number | K903298 |
Device Name: | DYNASONIC PLAQUE REMOVER & POLISHER DYNATIP |
Classification | Scaler, Ultrasonic |
Applicant | MICRO MOTORS, INC. 151 EAST COLUMBINE AVE. Santa Ana, CA 92707 |
Contact | Russ Reinsch |
Correspondent | Russ Reinsch MICRO MOTORS, INC. 151 EAST COLUMBINE AVE. Santa Ana, CA 92707 |
Product Code | ELC |
CFR Regulation Number | 872.4850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-24 |
Decision Date | 1991-04-16 |