The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Nobeldirect 3.0-immediate Load, 3.0 X 13 Mm And 3.0 X 15 Mm.
| Device ID | K070857 |
| 510k Number | K070857 |
| Device Name: | NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Phuong Nguyen Son |
| Correspondent | Phuong Nguyen Son NOBEL BIOCARE AB 22715 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 | 2007-03-28 |
| Decision Date | 2007-12-28 |
| Summary: | summary |