The following data is part of a premarket notification filed by North West Medical Instrument (group) Co., Ltd. with the FDA for Dental Handpiece.
| Device ID | K093971 |
| 510k Number | K093971 |
| Device Name: | DENTAL HANDPIECE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. # 19, LANE 999 ZHONGSHAN 2 RD SUITE 8D Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Dawn Tibodeau TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-12-24 |
| Decision Date | 2010-04-22 |
| Summary: | summary |