The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Dtx Studio Clinic 3.0.
| Device ID | K213562 |
| 510k Number | K213562 |
| Device Name: | DTX Studio Clinic 3.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Nobel Biocare AB Vastra Hamngatan 1 411 17 Goteborg, SE 402 26 |
| Contact | Wim Vrydag |
| Correspondent | Wim Vrydag 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 | 2021-11-09 |
| Decision Date | 2022-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747196344 | K213562 | 000 |
| 07332747200584 | K213562 | 000 |
| 07332747199772 | K213562 | 000 |
| 07332747199789 | K213562 | 000 |
| 07332747200867 | K213562 | 000 |
| 07332747200881 | K213562 | 000 |
| 07332747199796 | K213562 | 000 |
| 07332747199802 | K213562 | 000 |
| 07332747196320 | K213562 | 000 |
| 07332747200577 | K213562 | 000 |