The following data is part of a premarket notification filed by Biomet 3i with the FDA for Intergro Oral.
| Device ID | K070147 |
| 510k Number | K070147 |
| Device Name: | INTERGRO ORAL |
| Classification | Bone Grafting Material, Human Source |
| Applicant | BIOMET 3I 4555 RIVERSIDE DRIVE Palm Beach Gardens, FL 33410 |
| Contact | Tamara J Nelson |
| Correspondent | Tamara J Nelson BIOMET 3I 4555 RIVERSIDE DRIVE Palm Beach Gardens, FL 33410 |
| Product Code | NUN |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-16 |
| Decision Date | 2007-05-14 |
| Summary: | summary |