The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann Magellan(tm) Abutment,protective Cap,titanium Copings,gold Chopings,basal Screw.
| Device ID | K133421 |
| 510k Number | K133421 |
| Device Name: | STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Charlotte Ringleb |
| Correspondent | Charlotte Ringleb STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-08 |
| Decision Date | 2014-04-17 |
| Summary: | summary |