The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Dtx Studio Clinic.
| Device ID | K203156 |
| 510k Number | K203156 |
| Device Name: | DTX Studio Clinic |
| Classification | System, Image Processing, Radiological |
| Applicant | Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE Se-402 26 |
| Contact | Wim Vrydag |
| Correspondent | Vladislavs Mihailovs Nobel Biocare C/o Medicim NV Stationsstraat 102 Mechelen, BE 2800 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-22 |
| Decision Date | 2020-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747187045 | K203156 | 000 |
| 07332747187038 | K203156 | 000 |
| 07332747185850 | K203156 | 000 |
| 07332747185843 | K203156 | 000 |
| 07332747188097 | K203156 | 000 |
| 07332747188080 | K203156 | 000 |