The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Dtx Studio Diagnose.
| Device ID | K172224 |
| 510k Number | K172224 |
| Device Name: | DTX Studio Diagnose |
| Classification | System, Image Processing, Radiological |
| 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 Sasvi Ranch Parkway Yorba Linda, CA 92887 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-25 |
| Decision Date | 2018-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747153118 | K172224 | 000 |
| 07332747185775 | K172224 | 000 |
| 07332747178418 | K172224 | 000 |
| 07332747178425 | K172224 | 000 |
| 07332747172980 | K172224 | 000 |
| 07332747172997 | K172224 | 000 |
| 07332747166392 | K172224 | 000 |
| 07332747166408 | K172224 | 000 |
| 07332747152166 | K172224 | 000 |
| 07332747152173 | K172224 | 000 |
| 07332747153101 | K172224 | 000 |
| 07332747185768 | K172224 | 000 |