The following data is part of a premarket notification filed by Nobel Biocare Usa Llc with the FDA for Nobelreplace Tapered Conical Connection.
| Device ID | K062566 |
| 510k Number | K062566 |
| Device Name: | NOBELREPLACE TAPERED CONICAL CONNECTION |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Herbert Crane |
| Correspondent | Herbert Crane NOBEL BIOCARE USA LLC 22715 SAVI RANCH PARKWAY 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 | 2006-08-31 |
| Decision Date | 2006-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747088335 | K062566 | 000 |
| 07332747035759 | K062566 | 000 |
| 07332747035742 | K062566 | 000 |
| 07332747035735 | K062566 | 000 |
| 07332747035728 | K062566 | 000 |
| 07332747035711 | K062566 | 000 |
| 07332747035704 | K062566 | 000 |
| 07332747035698 | K062566 | 000 |
| 07332747035681 | K062566 | 000 |
| 07332747035674 | K062566 | 000 |
| 07332747035667 | K062566 | 000 |
| 07332747035650 | K062566 | 000 |
| 07332747035643 | K062566 | 000 |
| 07332747035636 | K062566 | 000 |
| 07332747034417 | K062566 | 000 |
| 07332747035766 | K062566 | 000 |
| 07332747035773 | K062566 | 000 |
| 07332747073508 | K062566 | 000 |
| 07332747073645 | K062566 | 000 |
| 07332747073638 | K062566 | 000 |
| 07332747073621 | K062566 | 000 |
| 07332747073614 | K062566 | 000 |
| 07332747073607 | K062566 | 000 |
| 07332747073591 | K062566 | 000 |
| 07332747073584 | K062566 | 000 |
| 07332747073577 | K062566 | 000 |
| 07332747073560 | K062566 | 000 |
| 07332747073553 | K062566 | 000 |
| 07332747073546 | K062566 | 000 |
| 07332747073539 | K062566 | 000 |
| 07332747073522 | K062566 | 000 |
| 07332747073515 | K062566 | 000 |
| 07332747034400 | K062566 | 000 |