The following data is part of a premarket notification filed by Microp Technology (taiwan), Inc. with the FDA for Dental High-speed Handpiece And Accessories.
Device ID | K173943 |
510k Number | K173943 |
Device Name: | Dental High-speed Handpiece And Accessories |
Classification | Handpiece, Air-powered, Dental |
Applicant | MicroP Technology (Taiwan), Inc. No.40, Junghe Tsuen, Minshiung Township Chiayi County, TW 621 |
Contact | Ina Lin |
Correspondent | Ina Lin MicroP Technology (Taiwan), Inc. No.40, Junghe Tsuen, Minshiung Township Chiayi County, TW 621 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-12-26 |
Decision Date | 2018-07-24 |
Summary: | summary |