The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelclinician, Dtx Studio Implant.
| Device ID | K163122 |
| 510k Number | K163122 |
| Device Name: | NobelClinician, DTX Studio Implant |
| Classification | System, Image Processing, Radiological |
| Applicant | NOBEL BIOCARE AB VASTRA HAMNGATAN 1 Goteborg, SE Se-411 17 |
| Contact | Chalemagne Chua |
| Correspondent | Chalemagne Chua NOBEL BIOCARE USA LLC 22715 SAVI 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 | 2016-11-08 |
| Decision Date | 2017-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747158809 | K163122 | 000 |
| 07332747181944 | K163122 | 000 |
| 07332747172829 | K163122 | 000 |
| 07332747172805 | K163122 | 000 |
| 07332747166101 | K163122 | 000 |
| 07332747166125 | K163122 | 000 |
| 07332747125153 | K163122 | 000 |
| 07332747125160 | K163122 | 000 |
| 07332747125177 | K163122 | 000 |
| 07332747128963 | K163122 | 000 |
| 07332747128970 | K163122 | 000 |
| 07332747158793 | K163122 | 000 |
| 07332747181937 | K163122 | 000 |