The following data is part of a premarket notification filed by Codent Technical Industry Co., Ltd. with the FDA for High Speed Handpieces And Accessories.
| Device ID | K152146 |
| 510k Number | K152146 |
| Device Name: | High Speed Handpieces And Accessories |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | CODENT TECHNICAL INDUSTRY CO., LTD. 5F., No.90, Luke 5th Rd., Luzhu District Kaohsiung City, TW 82151 |
| Contact | Chin-ting Wen |
| Correspondent | Chin-ting Wen CODENT TECHNICAL INDUSTRY CO., LTD. 5F., No.90, Luke 5th Rd., Luzhu District Kaohsiung City, TW 82151 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2015-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810113690971 | K152146 | 000 |
| 00810113690964 | K152146 | 000 |