The following data is part of a premarket notification filed by Microp Technology (taiwan), Inc. with the FDA for Dental Low-speed Handpieces And Accessories.
Device ID | K202786 |
510k Number | K202786 |
Device Name: | Dental Low-speed Handpieces And Accessories |
Classification | Handpiece, Air-powered, Dental |
Applicant | MicroP Technology (Taiwan), Inc. No.50, Zhongxiao 2nd St., East Dist, Chiayi City 600, Taiwan (R.O.C) Chiayi City, TW 600 |
Contact | Ina Lin |
Correspondent | Ina Lin MicroP Technology (Taiwan), Inc. No.50, Zhongxiao 2nd St., East Dist, Chiayi City 600, Taiwan (R.O.C) Chiayi City, TW 600 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-22 |
Decision Date | 2021-09-03 |