The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelzygoma 45°.
| Device ID | K152093 |
| 510k Number | K152093 |
| Device Name: | NobelZygoma 45° |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE AB BOX 5190, SE-402 26, VASTRA HAMNGATAN 1 Goteborg, SE Se-411 17 |
| Contact | Ji Eun Hwang |
| 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 | 2015-07-28 |
| Decision Date | 2016-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747102826 | K152093 | 000 |
| 07332747161625 | K152093 | 000 |
| 07332747161618 | K152093 | 000 |
| 07332747161601 | K152093 | 000 |
| 07332747161595 | K152093 | 000 |
| 07332747161588 | K152093 | 000 |
| 07332747161571 | K152093 | 000 |
| 07332747161564 | K152093 | 000 |
| 07332747161557 | K152093 | 000 |
| 07332747161632 | K152093 | 000 |
| 07332747102734 | K152093 | 000 |
| 07332747102819 | K152093 | 000 |
| 07332747102802 | K152093 | 000 |
| 07332747102796 | K152093 | 000 |
| 07332747102789 | K152093 | 000 |
| 07332747102772 | K152093 | 000 |
| 07332747102765 | K152093 | 000 |
| 07332747102758 | K152093 | 000 |
| 07332747102741 | K152093 | 000 |
| 07332747161540 | K152093 | 000 |