The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Inplant Orthodontic Anchor System.
| Device ID | K000643 |
| 510k Number | K000643 |
| Device Name: | INPLANT ORTHODONTIC ANCHOR SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE UAS INC 22725 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Jeff Hausheer |
| Correspondent | Jeff Hausheer NOBEL BIOCARE UAS INC 22725 SAVI RANCH PKWY. 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 | 2000-02-25 |
| Decision Date | 2000-09-07 |