The following data is part of a premarket notification filed by Biomet 3i, Inc. with the FDA for Cam Structsure Precision Milled Bars.
| Device ID | K080864 |
| 510k Number | K080864 |
| Device Name: | CAM STRUCTSURE PRECISION MILLED BARS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | BIOMET 3I, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | Tamara West |
| Correspondent | Tamara West BIOMET 3I, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-28 |
| Decision Date | 2008-07-21 |
| Summary: | summary |