The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Dtx Studio Design.
| Device ID | K181932 |
| 510k Number | K181932 |
| Device Name: | DTX Studio Design |
| Classification | Dental Abutment Design Software For Dental Laboratory |
| 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 | PNP |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-19 |
| Decision Date | 2019-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747157932 | K181932 | 000 |
| 07332747157949 | K181932 | 000 |
| 07332747180756 | K181932 | 000 |
| 07332747173314 | K181932 | 000 |