The following data is part of a premarket notification filed by Pou Yu Biotechnology Co., Ltd. with the FDA for Tds Abutment.
| Device ID | K081460 |
| 510k Number | K081460 |
| Device Name: | TDS ABUTMENT |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | POU YU BIOTECHNOLOGY CO., LTD. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Linda K Schulz |
| Correspondent | Linda K Schulz POU YU BIOTECHNOLOGY CO., LTD. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-23 |
| Decision Date | 2008-11-21 |
| Summary: | summary |