The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobeldesign Software.
| Device ID | K153036 |
| 510k Number | K153036 |
| Device Name: | NobelDesign Software |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE AB BOX 5190, SE-402 26, VASTRA HAMNAGATAN 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-19 |
| Decision Date | 2016-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747124736 | K153036 | 000 |
| 07332747106268 | K153036 | 000 |