The following data is part of a premarket notification filed by Acucera, Inc. with the FDA for Zirace.
| Device ID | K051501 |
| 510k Number | K051501 |
| Device Name: | ZIRACE |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ACUCERA, INC. NAMYANGJU-SI GYEONGGI Seul, KR 472-861 |
| Contact | Kyung-bin Lee |
| Correspondent | Kyung-bin Lee ACUCERA, INC. NAMYANGJU-SI GYEONGGI Seul, KR 472-861 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-06 |
| Decision Date | 2005-10-19 |
| Summary: | summary |