The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Pureset Tray.
| Device ID | K181075 |
| 510k Number | K181075 |
| Device Name: | PureSet Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| 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 | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-24 |
| Decision Date | 2018-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747149982 | K181075 | 000 |
| 07332747149999 | K181075 | 000 |
| 07332747150001 | K181075 | 000 |
| 07332747150018 | K181075 | 000 |
| 07332747169072 | K181075 | 000 |
| 07332747169089 | K181075 | 000 |
| 07332747169065 | K181075 | 000 |
| 07332747169034 | K181075 | 000 |
| 07332747169041 | K181075 | 000 |
| 07332747169058 | K181075 | 000 |
| 07332747149975 | K181075 | 000 |
| 07332747149968 | K181075 | 000 |