The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelzygoma 0°.
| Device ID | K183069 |
| 510k Number | K183069 |
| Device Name: | NobelZygoma 0° |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Nobel Biocare AB Box 5190, SE-402 26, Vastra Hamngatan 1 Goteborg, SE Se-411 17 |
| Contact | Charlemagne Chua |
| Correspondent | Charlemagne Chua Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887 |
| Product Code | DZE |
| Subsequent Product Code | DZI |
| Subsequent Product Code | NHA |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-05 |
| Decision Date | 2018-12-04 |
| Summary: | summary |