The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Multi-unit Abutment Plus.
| Device ID | K161416 |
| 510k Number | K161416 |
| Device Name: | Multi-unit Abutment Plus |
| 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 | 2016-05-23 |
| Decision Date | 2017-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747116342 | K161416 | 000 |
| 07332747116052 | K161416 | 000 |
| 07332747116045 | K161416 | 000 |
| 07332747116038 | K161416 | 000 |
| 07332747116021 | K161416 | 000 |
| 07332747116014 | K161416 | 000 |
| 07332747116007 | K161416 | 000 |
| 07332747115994 | K161416 | 000 |
| 07332747115987 | K161416 | 000 |
| 07332747116069 | K161416 | 000 |
| 07332747116076 | K161416 | 000 |
| 07332747116083 | K161416 | 000 |
| 07332747116168 | K161416 | 000 |
| 07332747116151 | K161416 | 000 |
| 07332747116144 | K161416 | 000 |
| 07332747116137 | K161416 | 000 |
| 07332747116120 | K161416 | 000 |
| 07332747116113 | K161416 | 000 |
| 07332747116106 | K161416 | 000 |
| 07332747116090 | K161416 | 000 |
| 07332747115970 | K161416 | 000 |