The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Onplant Orthodontic System.
| Device ID | K980460 |
| 510k Number | K980460 |
| Device Name: | ONPLANT ORTHODONTIC SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont, IL 60559 |
| Contact | Betsy A Brown |
| Correspondent | Betsy A Brown NOBEL BIOCARE UAS INC 777 OAKMONT LANE, SUITE 100 Westmont, IL 60559 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-02 |
| Decision Date | 1998-05-05 |
| Summary: | summary |