The following data is part of a premarket notification filed by Straumann Usa with the FDA for Straumann Cares Screw-retained Bridge Titanium, Straumann Cares Dolder Bar Titanium.
| Device ID | K112280 |
| 510k Number | K112280 |
| Device Name: | STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM |
| 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 | 2011-08-09 |
| Decision Date | 2011-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031702081 | K112280 | 000 |
| 07630031702203 | K112280 | 000 |
| 07630031702210 | K112280 | 000 |
| 07630031702227 | K112280 | 000 |
| 07630031702234 | K112280 | 000 |
| 07630031702241 | K112280 | 000 |
| 07630031702258 | K112280 | 000 |
| 07630031702265 | K112280 | 000 |
| 07630031702272 | K112280 | 000 |
| 07630031702197 | K112280 | 000 |
| 07630031702180 | K112280 | 000 |
| 07630031702173 | K112280 | 000 |
| 07630031702098 | K112280 | 000 |
| 07630031702104 | K112280 | 000 |
| 07630031702111 | K112280 | 000 |
| 07630031702128 | K112280 | 000 |
| 07630031702135 | K112280 | 000 |
| 07630031702142 | K112280 | 000 |
| 07630031702159 | K112280 | 000 |
| 07630031702166 | K112280 | 000 |
| 07630031702289 | K112280 | 000 |
| 07630031702296 | K112280 | 000 |
| 07630031702302 | K112280 | 000 |
| 07630031702623 | K112280 | 000 |
| 07630031702630 | K112280 | 000 |
| 07630031702647 | K112280 | 000 |
| 07630031702654 | K112280 | 000 |
| 07630031702661 | K112280 | 000 |
| 07630031702678 | K112280 | 000 |
| 07630031702685 | K112280 | 000 |
| 07630031702692 | K112280 | 000 |
| 07630031702616 | K112280 | 000 |
| 07630031702517 | K112280 | 000 |
| 07630031702500 | K112280 | 000 |
| 07630031702319 | K112280 | 000 |
| 07630031702432 | K112280 | 000 |
| 07630031702449 | K112280 | 000 |
| 07630031702456 | K112280 | 000 |
| 07630031702463 | K112280 | 000 |
| 07630031702470 | K112280 | 000 |
| 07630031702487 | K112280 | 000 |
| 07630031702494 | K112280 | 000 |
| 07630031711892 | K112280 | 000 |