The following data is part of a premarket notification filed by Codent Technical Industry Co., Ltd. with the FDA for Codent Low Speed Dental Handpieces And Accessories.
| Device ID | K133069 |
| 510k Number | K133069 |
| Device Name: | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | CODENT TECHNICAL INDUSTRY CO., LTD. 5F., No.90, Luke 5th Rd., Luzhu District SOUTHERN TAIWAN SCIENCE PARK 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 SOUTHERN TAIWAN SCIENCE PARK 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 | 2013-09-30 |
| Decision Date | 2014-10-24 |
| Summary: | summary |