The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Blt 02.9mm Sc, Sla Or Slactive, Rxd, Loxim, Sc Closure Cap And Healing Abutments, Sc Temporary Abutments, Sc Variobase Abutments, Sc Cares Abutment.
| Device ID | K162890 |
| 510k Number | K162890 |
| Device Name: | BLT 02.9mm SC, SLA Or SLActive, RXD, Loxim, SC Closure Cap And Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Jennifer M. Jackson |
| Correspondent | Jennifer M. Jackson STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-17 |
| Decision Date | 2017-03-08 |
| Summary: | summary |