The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Trefoil System.
| Device ID | K170135 |
| 510k Number | K170135 |
| Device Name: | TREFOIL System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Nobel Biocare AB BOX 5190, SE-402 26, Vastra Hamngatan 1 Goteberg, 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-17 |
| Decision Date | 2017-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747124590 | K170135 | 000 |
| 07332747124255 | K170135 | 000 |
| 07332747124248 | K170135 | 000 |
| 07332747124231 | K170135 | 000 |
| 07332747124224 | K170135 | 000 |
| 07332747124217 | K170135 | 000 |
| 07332747124200 | K170135 | 000 |
| 17332747009337 | K170135 | 000 |
| 17332747009320 | K170135 | 000 |
| 07332747124262 | K170135 | 000 |
| 07332747124279 | K170135 | 000 |
| 07332747124408 | K170135 | 000 |
| 07332747124491 | K170135 | 000 |
| 07332747124484 | K170135 | 000 |
| 07332747124477 | K170135 | 000 |
| 07332747124460 | K170135 | 000 |
| 07332747124453 | K170135 | 000 |
| 07332747124446 | K170135 | 000 |
| 07332747124439 | K170135 | 000 |
| 07332747124422 | K170135 | 000 |
| 17332747009313 | K170135 | 000 |