The following data is part of a premarket notification filed by Nobelbiocare Ab with the FDA for Multi- Unit Abutments For Straumann And Astra Tech Implant Systems.
| Device ID | K093643 |
| 510k Number | K093643 |
| Device Name: | MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | NOBELBIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Contact | Herbert Crane |
| Correspondent | Herbert Crane NOBELBIOCARE AB 22715 SAVI RANCH PARKWAY Yorba Linda, CA 92887 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-25 |
| Decision Date | 2010-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332747017878 | K093643 | 000 |
| 07332747011685 | K093643 | 000 |
| 07332747011692 | K093643 | 000 |
| 07332747011708 | K093643 | 000 |
| 07332747011715 | K093643 | 000 |
| 07332747011722 | K093643 | 000 |
| 07332747011739 | K093643 | 000 |
| 07332747011746 | K093643 | 000 |
| 07332747011753 | K093643 | 000 |
| 07332747011678 | K093643 | 000 |
| 07332747011494 | K093643 | 000 |
| 07332747011418 | K093643 | 000 |
| 07332747011425 | K093643 | 000 |
| 07332747011432 | K093643 | 000 |
| 07332747011449 | K093643 | 000 |
| 07332747011456 | K093643 | 000 |
| 07332747011463 | K093643 | 000 |
| 07332747011470 | K093643 | 000 |
| 07332747011487 | K093643 | 000 |
| 07332747011760 | K093643 | 000 |
| 07332747017564 | K093643 | 000 |
| 07332747017793 | K093643 | 000 |
| 07332747017809 | K093643 | 000 |
| 07332747017816 | K093643 | 000 |
| 07332747017823 | K093643 | 000 |
| 07332747017830 | K093643 | 000 |
| 07332747017847 | K093643 | 000 |
| 07332747017854 | K093643 | 000 |
| 07332747017861 | K093643 | 000 |
| 07332747017786 | K093643 | 000 |
| 07332747017779 | K093643 | 000 |
| 07332747017571 | K093643 | 000 |
| 07332747017588 | K093643 | 000 |
| 07332747017595 | K093643 | 000 |
| 07332747017601 | K093643 | 000 |
| 07332747017618 | K093643 | 000 |
| 07332747017625 | K093643 | 000 |
| 07332747017755 | K093643 | 000 |
| 07332747017762 | K093643 | 000 |
| 07332747011401 | K093643 | 000 |