The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Kit Boxes And Kit Plates.
| Device ID | K163600 |
| 510k Number | K163600 |
| Device Name: | Kit Boxes And Kit Plates |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE Se-411 17 |
| Contact | Charlemagne Chua |
| Correspondent | Chalemagne Chua Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-21 |
| Decision Date | 2018-01-22 |
| Summary: | summary |