The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Various Branemark System Implants-immediate Function Indication.
| Device ID | K022562 |
| 510k Number | K022562 |
| Device Name: | VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE AB 22725 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Kathleen Dragovich |
| Correspondent | Kathleen Dragovich NOBEL BIOCARE AB 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 | 2002-08-02 |
| Decision Date | 2002-10-11 |
| Summary: | summary |