The following data is part of a premarket notification filed by Nobel Biocare Uas Inc with the FDA for Replace One Piece Implant, Ha, Replace One Piece Implant, Tiunite.
| Device ID | K023952 |
| 510k Number | K023952 |
| Device Name: | REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE UAS INC 22715 SAVI RANCH PKWY. Yorba Linda, CA 92887 |
| Contact | Katheleen Dragovich |
| Correspondent | Katheleen Dragovich 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 | 2002-11-27 |
| Decision Date | 2003-01-16 |
| Summary: | summary |