The following data is part of a premarket notification filed by Jindell Medical Instruments Co., Ltd. with the FDA for Jindell High Spped Air Turbine Handpiece, Models Sw, Sp, Su, Etu, Mu.
| Device ID | K062740 |
| 510k Number | K062740 |
| Device Name: | JINDELL HIGH SPPED AIR TURBINE HANDPIECE, MODELS SW, SP, SU, ETU, MU |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | JINDELL MEDICAL INSTRUMENTS CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen JINDELL MEDICAL INSTRUMENTS CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-13 |
| Decision Date | 2006-11-02 |
| Summary: | summary |