The following data is part of a premarket notification filed by Peng Lim Enterprise Co., Ltd. with the FDA for High Speed Air Turbine Handpiece, Models Super-air And Super-qd Series.
| Device ID | K062947 |
| 510k Number | K062947 |
| Device Name: | HIGH SPEED AIR TURBINE HANDPIECE, MODELS SUPER-AIR AND SUPER-QD SERIES |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | PENG LIM ENTERPRISE CO., LTD. NO. 58 FU-CHIUN STREET Hsin-chu City, TW |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen PENG LIM ENTERPRISE CO., LTD. NO. 58 FU-CHIUN STREET Hsin-chu City, TW |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-28 |
| Decision Date | 2006-12-14 |
| Summary: | summary |