The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for On1 Concept.
| Device ID | K161655 |
| 510k Number | K161655 |
| Device Name: | On1 Concept |
| 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 | 2016-06-16 |
| Decision Date | 2017-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747113853 | K161655 | 000 |
| 07332747113365 | K161655 | 000 |
| 07332747113358 | K161655 | 000 |
| 07332747113341 | K161655 | 000 |
| 07332747113334 | K161655 | 000 |
| 07332747113327 | K161655 | 000 |
| 07332747113310 | K161655 | 000 |
| 07332747113303 | K161655 | 000 |
| 07332747113297 | K161655 | 000 |
| 07332747113280 | K161655 | 000 |
| 07332747113273 | K161655 | 000 |
| 07332747113266 | K161655 | 000 |
| 07332747113259 | K161655 | 000 |
| 07332747113389 | K161655 | 000 |
| 07332747113402 | K161655 | 000 |
| 07332747113846 | K161655 | 000 |
| 07332747113839 | K161655 | 000 |
| 07332747113822 | K161655 | 000 |
| 07332747113815 | K161655 | 000 |
| 07332747113808 | K161655 | 000 |
| 07332747113792 | K161655 | 000 |
| 07332747113532 | K161655 | 000 |
| 07332747113525 | K161655 | 000 |
| 07332747113518 | K161655 | 000 |
| 07332747113501 | K161655 | 000 |
| 07332747113495 | K161655 | 000 |
| 07332747113488 | K161655 | 000 |
| 07332747113242 | K161655 | 000 |