Straumann USA, LLC
Straumann USA, LLC holds FDA 510(k) medical device clearances, first cleared 2012, most recent 2024, with 21 FDA device recalls on record.
Top product codes for Straumann USA, LLC
FDA recalls by Straumann USA, LLC
10 most recent of 21- Z-2935-2026 — Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form
- Z-2929-2026 — GM Helix Implant, Endosseous Dental Implant Article No. 109.984
- Z-1995-2026 — Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
- Z-1994-2026 — Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
- Z-1632-2026 — Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
- Z-1633-2026 — Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
- Z-1337-2026 — WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
- Z-0582-2026 — Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
- Z-1863-2025 — GM Helix Acqua Implant, Article Number: 140.985
- Z-1862-2025 — GM Helix Acqua Implant, Article Number: 140.984
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Straumann USA, LLC
- K241575 — Straumann® Anatomic Healing Abutments XC (AHA)
- K203753 — Straumann Surgical Cassettes
- K202942 — Straumann 4 mm Short Implants
- K192401 — Straumann Screw-Retained Abutments
- K190662 — MRI Compatibility for Existing Straumann Dental Implant Systems
- K171784 — Straumann Dental Implant System
- K162890 — BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
- K151590 — Straumann RN Gold Abutment for Bridge
- K150899 — Straumann CARES Titanium Alloy (TAN) Abutment
- K151324 — Straumann Variobase for CEREC
- K150814 — Straumann Screw-Retained Abutment
- K151247 — NC Straumann Screw Retained Abutments
- K151157 — NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges
- K150938 — Straumann® Dental Implant System ¿ Roxolid® SLA Implants
- K142890 — Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit
- K140878 — STRAUMANN BONE LEVEL TAPERED IMPLANT
- K140737 — STRAUMANN CARES SCREW RETAINED BARS/BRIDGE
- K141871 — Straumann Bone Level NC Angled Screw Retained Abutments
- K133421 — STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREW
- K132219 — STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,
- K132844 — STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES
- K130222 — STRAUMANN DENTAL IMPLANT SYSTEM
- K123784 — STRAUMANN DENTAL IMPLANT SYSTEM
- K122192 — NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.