The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobelspeedy Groovy.
| Device ID | K160119 |
| 510k Number | K160119 |
| Device Name: | NobelSpeedy Groovy |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE AB VASTRA HAMNGATAN 1 Goteborg, SE Se-411 17 |
| Contact | Charlemagne Chua |
| Correspondent | Chalemagne Chua NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-19 |
| Decision Date | 2016-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747086263 | K160119 | 000 |
| 07332747086256 | K160119 | 000 |
| 07332747086249 | K160119 | 000 |
| 07332747161045 | K160119 | 000 |
| 07332747161038 | K160119 | 000 |
| 07332747161021 | K160119 | 000 |