The following data is part of a premarket notification filed by Nobel Biocare Ab with the FDA for Sfb & Cfb Implants.
| Device ID | K061003 |
| 510k Number | K061003 |
| Device Name: | SFB & CFB IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBEL BIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Herbert Crane |
| Correspondent | Herbert Crane NOBEL BIOCARE AB 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 | 2006-04-11 |
| Decision Date | 2006-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747088229 | K061003 | 000 |
| 07332747023992 | K061003 | 000 |
| 07332747024005 | K061003 | 000 |
| 07332747024012 | K061003 | 000 |
| 07332747024029 | K061003 | 000 |
| 07332747034288 | K061003 | 000 |
| 07332747034295 | K061003 | 000 |
| 07332747034301 | K061003 | 000 |
| 07332747034318 | K061003 | 000 |
| 07332747088212 | K061003 | 000 |
| 07332747020229 | K061003 | 000 |