Straumann USA LLC
Summary
- Total Recalls
- 15
- 510(k) Clearances
- 66
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1337-2026 | Class III | WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM | January 6, 2026 |
| Z-0582-2026 | Class II | Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; | October 17, 2025 |
| Z-1863-2025 | Class II | GM Helix Acqua Implant, Article Number: 140.985 | May 1, 2025 |
| Z-1862-2025 | Class II | GM Helix Acqua Implant, Article Number: 140.984 | May 1, 2025 |
| Z-1671-2025 | Class II | WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments. | April 17, 2025 |
| Z-1861-2025 | Class II | Plus Initial Drill, Article Number: 103.170; | April 14, 2025 |
| Z-1561-2025 | Class II | TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002; | March 8, 2025 |
| Z-0512-2022 | Class II | Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089 | November 30, 2021 |
| Z-0513-2022 | Class II | Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107 | November 30, 2021 |
| Z-2336-2021 | Class II | KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances | June 25, 2021 |
| Z-2198-2021 | Class II | Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046 | May 27, 2021 |
| Z-0981-2015 | Class II | Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous | October 27, 2014 |
| Z-0174-2015 | Class II | Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 | September 24, 2014 |
| Z-0117-2015 | Class II | Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 | September 19, 2014 |
| Z-2161-2012 | Class II | Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Num | July 11, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA) | November 11, 2024 |
| K203753 | Straumann Surgical Cassettes | July 29, 2021 |
| K202942 | Straumann 4 mm Short Implants | February 8, 2021 |
| K192401 | Straumann Screw-Retained Abutments | April 6, 2020 |
| K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems | June 17, 2019 |
| K171784 | Straumann Dental Implant System | January 19, 2018 |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutm | March 8, 2017 |
| K151590 | Straumann RN Gold Abutment for Bridge | March 4, 2016 |
| K151328 | PURE Ceramic Implants | January 11, 2016 |
| K150899 | Straumann CARES Titanium Alloy (TAN) Abutment | September 16, 2015 |
| K151324 | Straumann Variobase for CEREC | September 11, 2015 |
| K150814 | Straumann Screw-Retained Abutment | August 10, 2015 |
| K151247 | NC Straumann Screw Retained Abutments | August 10, 2015 |
| K151157 | NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, | August 5, 2015 |
| K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | July 24, 2015 |
| K142890 | Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, | January 9, 2015 |
| K140878 | STRAUMANN BONE LEVEL TAPERED IMPLANT | August 20, 2014 |
| K140737 | STRAUMANN CARES SCREW RETAINED BARS/BRIDGE | August 14, 2014 |
| K141871 | Straumann Bone Level NC Angled Screw Retained Abutments | August 7, 2014 |
| K133421 | STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW | April 17, 2014 |