The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelzygoma 0°.
| Device ID | K161598 |
| 510k Number | K161598 |
| Device Name: | NobelZygoma 0° |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Nobel Biocare AB Box 5190, SE-402 26, Vastra Hamngatan I 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 |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-09 |
| Decision Date | 2017-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747112405 | K161598 | 000 |
| 07332747086133 | K161598 | 000 |
| 07332747086126 | K161598 | 000 |
| 07332747161533 | K161598 | 000 |
| 07332747161526 | K161598 | 000 |
| 07332747161519 | K161598 | 000 |
| 07332747161502 | K161598 | 000 |
| 07332747161496 | K161598 | 000 |
| 07332747161489 | K161598 | 000 |
| 07332747161472 | K161598 | 000 |
| 07332747086140 | K161598 | 000 |
| 07332747089141 | K161598 | 000 |
| 07332747102727 | K161598 | 000 |
| 07332747102710 | K161598 | 000 |
| 07332747102703 | K161598 | 000 |
| 07332747098792 | K161598 | 000 |
| 07332747098785 | K161598 | 000 |
| 07332747098778 | K161598 | 000 |
| 07332747098761 | K161598 | 000 |
| 07332747098754 | K161598 | 000 |
| 07332747089158 | K161598 | 000 |
| 07332747161465 | K161598 | 000 |