The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobeldesign, Dtx Studio Design.
| Device ID | K171466 |
| 510k Number | K171466 |
| Device Name: | NobelDesign, DTX Studio Design |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE Se-411 17 |
| Contact | Charlemagne Chua |
| Correspondent | Charlemagne Chua Nobel Biocare USA LLC 22715 Sasvi Ranch Parkway Yorba Linda, CA 92887 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-18 |
| Decision Date | 2017-11-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747155358 | K171466 | 000 |
| 07332747149487 | K171466 | 000 |
| 07332747126464 | K171466 | 000 |
| 07332747125191 | K171466 | 000 |