The following data is part of a premarket notification filed by Pou Yu Biotechnology Co., Ltd. with the FDA for Tds Titanium Abutment For Nobel Biocare Branemark.
| Device ID | K091392 |
| 510k Number | K091392 |
| Device Name: | TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | POU YU BIOTECHNOLOGY CO., LTD. NO. 6, FUGONG RD. Fusing Township, Changhua Cty, TW 506 |
| Contact | Daniel Tsao |
| Correspondent | Daniel Tsao POU YU BIOTECHNOLOGY CO., LTD. NO. 6, FUGONG RD. Fusing Township, Changhua Cty, TW 506 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-11 |
| Decision Date | 2009-07-30 |
| Summary: | summary |