The following data is part of a premarket notification filed by Beijing Dongbo Dental Handpiece Co., Ltd. with the FDA for High-speed Turbine Handpieces For Single Use.
| Device ID | K172543 |
| 510k Number | K172543 |
| Device Name: | High-speed Turbine Handpieces For Single Use |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | Beijing Dongbo Dental Handpiece Co., Ltd. Room 201, Building 4, No.9 Anqing Street Area B Of Tianzhu Airport Industrial Beijing, CN 101318 |
| Contact | Chengfei Yan |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O.BOX 120-119 Shanghai, CN 200120 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-23 |
| Decision Date | 2018-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970278690125 | K172543 | 000 |
| 06970278690477 | K172543 | 000 |
| 06970278690460 | K172543 | 000 |
| 06970278690453 | K172543 | 000 |
| 06970278690446 | K172543 | 000 |
| 06970278690439 | K172543 | 000 |
| 06970278690422 | K172543 | 000 |
| 06970278690293 | K172543 | 000 |
| 06970278690408 | K172543 | 000 |
| 06970278690392 | K172543 | 000 |
| 06970278690385 | K172543 | 000 |
| 06970278690484 | K172543 | 000 |
| 06970278690019 | K172543 | 000 |
| 06970278690118 | K172543 | 000 |
| 06970278690101 | K172543 | 000 |
| 06970278690095 | K172543 | 000 |
| 06970278690088 | K172543 | 000 |
| 06970278690071 | K172543 | 000 |
| 06970278690064 | K172543 | 000 |
| 06970278690057 | K172543 | 000 |
| 06970278690040 | K172543 | 000 |
| 06970278690033 | K172543 | 000 |
| 06970278690026 | K172543 | 000 |
| 06970278690378 | K172543 | 000 |