The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Carbon Fiber Bridge, Model 28757.
| Device ID | K031070 |
| 510k Number | K031070 |
| Device Name: | CARBON FIBER BRIDGE, MODEL 28757 |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | NOBEL BIOCARE AB 22725 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Elizabeth J Mason |
| Correspondent | Elizabeth J Mason NOBEL BIOCARE AB 22725 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-04 |
| Decision Date | 2003-07-03 |
| Summary: | summary |