The following data is part of a premarket notification filed by Straumann Usa with the FDA for Cementable Abuntments; Temporary Copings; Protective Caps.
| Device ID | K080286 |
| 510k Number | K080286 |
| Device Name: | CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan STRAUMANN USA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-04 |
| Decision Date | 2008-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031739070 | K080286 | 000 |
| 07630031700391 | K080286 | 000 |
| 07630031700407 | K080286 | 000 |
| 07630031700414 | K080286 | 000 |
| 07630031700421 | K080286 | 000 |
| 07630031700438 | K080286 | 000 |
| 07630031700445 | K080286 | 000 |
| 07630031700452 | K080286 | 000 |
| 07630031700469 | K080286 | 000 |
| 07630031739322 | K080286 | 000 |
| 07630031739315 | K080286 | 000 |
| 07630031739308 | K080286 | 000 |
| 07630031739087 | K080286 | 000 |
| 07630031739094 | K080286 | 000 |
| 07630031739100 | K080286 | 000 |
| 07630031739117 | K080286 | 000 |
| 07630031739124 | K080286 | 000 |
| 07630031739278 | K080286 | 000 |
| 07630031739285 | K080286 | 000 |
| 07630031739292 | K080286 | 000 |
| 07630031700476 | K080286 | 000 |
| 07630031700483 | K080286 | 000 |
| 07630031700490 | K080286 | 000 |
| 07630031713551 | K080286 | 000 |
| 07630031713568 | K080286 | 000 |
| 07630031713575 | K080286 | 000 |
| 07630031713582 | K080286 | 000 |
| 07630031713599 | K080286 | 000 |
| 07630031713605 | K080286 | 000 |
| 07630031713612 | K080286 | 000 |
| 07630031713629 | K080286 | 000 |
| 07630031711823 | K080286 | 000 |
| 07630031710420 | K080286 | 000 |
| 07630031710413 | K080286 | 000 |
| 07630031700506 | K080286 | 000 |
| 07630031709370 | K080286 | 000 |
| 07630031709394 | K080286 | 000 |
| 07630031709400 | K080286 | 000 |
| 07630031710307 | K080286 | 000 |
| 07630031710314 | K080286 | 000 |
| 07630031710321 | K080286 | 000 |
| 07630031710369 | K080286 | 000 |
| 07630031713636 | K080286 | 000 |