The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Trefoil System.
| Device ID | K172352 |
| 510k Number | K172352 |
| Device Name: | TREFOIL System |
| 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 |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-03 |
| Decision Date | 2017-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747102888 | K172352 | 000 |
| 07332747102864 | K172352 | 000 |
| 07332747161670 | K172352 | 000 |
| 07332747161656 | K172352 | 000 |