The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Nobelreplace Adapter, Model 32412.
| Device ID | K050444 |
| 510k Number | K050444 |
| Device Name: | NOBELREPLACE ADAPTER, MODEL 32412 |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBEL BIOCARE UAS INC 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Elizabeth J Mason |
| Correspondent | Elizabeth J Mason NOBEL BIOCARE UAS INC 22715 SAVI RANCH PKWY. 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 | 2005-02-22 |
| Decision Date | 2005-07-07 |
| Summary: | summary |