The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Nobel Direct, Models 30937, 30938.
| Device ID | K031345 |
| 510k Number | K031345 |
| Device Name: | NOBEL DIRECT, MODELS 30937, 30938 |
| Classification | Implant, Endosseous, Root-form |
| 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 | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-29 |
| Decision Date | 2003-07-24 |
| Summary: | summary |