The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for On1 Universal Abutment.
| Device ID | K181869 |
| 510k Number | K181869 |
| Device Name: | On1 Universal Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 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 | 2018-07-12 |
| Decision Date | 2018-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747166866 | K181869 | 000 |
| 07332747113709 | K181869 | 000 |
| 07332747113716 | K181869 | 000 |
| 07332747113723 | K181869 | 000 |
| 07332747113730 | K181869 | 000 |
| 07332747113747 | K181869 | 000 |
| 07332747166811 | K181869 | 000 |
| 07332747166828 | K181869 | 000 |
| 07332747166835 | K181869 | 000 |
| 07332747166842 | K181869 | 000 |
| 07332747166859 | K181869 | 000 |
| 07332747113693 | K181869 | 000 |