The following data is part of a premarket notification filed by Codent Technical Industry Co., Ltd. with the FDA for Codent Dental Air-powered Handpiece, Model Hps.
| Device ID | K033213 |
| 510k Number | K033213 |
| Device Name: | CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | CODENT TECHNICAL INDUSTRY CO., LTD. NO.58, FU-CHUIN STREET Hsin-chu City, TW Roc |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min CODENT TECHNICAL INDUSTRY CO., LTD. NO.58, FU-CHUIN STREET Hsin-chu City, TW Roc |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-03 |
| Decision Date | 2004-02-06 |
| Summary: | summary |