The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Nobel Biocare's Modified Surface Implant (intended For Immediate Loading Upon Placement).
| Device ID | K993595 |
| 510k Number | K993595 |
| Device Name: | NOBEL BIOCARE'S MODIFIED SURFACE IMPLANT (INTENDED FOR IMMEDIATE LOADING UPON PLACEMENT) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE UAS INC 22725 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Jeff Hausheer |
| Correspondent | Jeff Hausheer NOBEL BIOCARE UAS INC 22725 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 | 1999-10-25 |
| Decision Date | 2000-01-28 |
| Summary: | summary |