The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Angulated Abutment, Complete,titanium Sdca 102.
| Device ID | K905434 |
| 510k Number | K905434 |
| Device Name: | ANGULATED ABUTMENT, COMPLETE,TITANIUM SDCA 102 |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Contact | Thomas Maldoon |
| Correspondent | Thomas Maldoon NOBELPHARMA USA, INC. 333 WEST WACKER DR. SUITE 2600 Chicago, IL 60606 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-04 |
| Decision Date | 1992-08-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17332747000020 | K905434 | 000 |
| 07332747003086 | K905434 | 000 |
| 07332747003093 | K905434 | 000 |
| 07332747003109 | K905434 | 000 |
| 07332747003116 | K905434 | 000 |
| 07332747003123 | K905434 | 000 |
| 07332747003130 | K905434 | 000 |
| 07332747003451 | K905434 | 000 |
| 07332747003468 | K905434 | 000 |
| 07332747003079 | K905434 | 000 |
| 07332747003062 | K905434 | 000 |
| 07332747003055 | K905434 | 000 |
| 07332747000191 | K905434 | 000 |
| 07332747000207 | K905434 | 000 |
| 07332747000214 | K905434 | 000 |
| 07332747000221 | K905434 | 000 |
| 07332747000825 | K905434 | 000 |
| 07332747000832 | K905434 | 000 |
| 07332747000849 | K905434 | 000 |
| 07332747000856 | K905434 | 000 |
| 07332747003475 | K905434 | 000 |
| 07332747003482 | K905434 | 000 |
| 07332747003659 | K905434 | 000 |
| 07332747012347 | K905434 | 000 |
| 07332747013894 | K905434 | 000 |
| 07332747015164 | K905434 | 000 |
| 07332747016086 | K905434 | 000 |
| 07332747016116 | K905434 | 000 |
| 07332747016123 | K905434 | 000 |
| 07332747017700 | K905434 | 000 |
| 07332747003642 | K905434 | 000 |
| 07332747003635 | K905434 | 000 |
| 07332747003628 | K905434 | 000 |
| 07332747003499 | K905434 | 000 |
| 07332747003550 | K905434 | 000 |
| 07332747003567 | K905434 | 000 |
| 07332747003574 | K905434 | 000 |
| 07332747003581 | K905434 | 000 |
| 07332747003598 | K905434 | 000 |
| 07332747003604 | K905434 | 000 |
| 07332747003611 | K905434 | 000 |
| 07332747017717 | K905434 | 000 |