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Straumann USA LLC

FDA Regulatory Profile

Summary

Total Recalls
17
510(k) Clearances
66
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1632-2026Class IICustom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;March 17, 2026
Z-1633-2026Class IICustom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;March 17, 2026
Z-1337-2026Class IIIWB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POMJanuary 6, 2026
Z-0582-2026Class IIEmdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;October 17, 2025
Z-1862-2025Class IIGM Helix Acqua Implant, Article Number: 140.984May 1, 2025
Z-1863-2025Class IIGM Helix Acqua Implant, Article Number: 140.985May 1, 2025
Z-1671-2025Class IIWB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.April 17, 2025
Z-1861-2025Class IIPlus Initial Drill, Article Number: 103.170;April 14, 2025
Z-1561-2025Class IITLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;March 8, 2025
Z-0513-2022Class IINeodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107November 30, 2021
Z-0512-2022Class IINeodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089November 30, 2021
Z-2336-2021Class IIKeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliancesJune 25, 2021
Z-2198-2021Class IIStraumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046May 27, 2021
Z-0981-2015Class IIDrill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S EndosseousOctober 27, 2014
Z-0174-2015Class IIStraumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 September 24, 2014
Z-0117-2015Class IIStraumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021September 19, 2014
Z-2161-2012Class IIStraumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article NumJuly 11, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K241575Straumann® Anatomic Healing Abutments XC (AHA)November 11, 2024
K203753Straumann Surgical CassettesJuly 29, 2021
K202942Straumann 4 mm Short ImplantsFebruary 8, 2021
K192401Straumann Screw-Retained AbutmentsApril 6, 2020
K190662MRI Compatibility for Existing Straumann Dental Implant SystemsJune 17, 2019
K171784Straumann Dental Implant SystemJanuary 19, 2018
K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary AbutmMarch 8, 2017
K151590Straumann RN Gold Abutment for BridgeMarch 4, 2016
K151328PURE Ceramic ImplantsJanuary 11, 2016
K150899Straumann CARES Titanium Alloy (TAN) AbutmentSeptember 16, 2015
K151324Straumann Variobase for CERECSeptember 11, 2015
K151247NC Straumann Screw Retained AbutmentsAugust 10, 2015
K150814Straumann Screw-Retained AbutmentAugust 10, 2015
K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, August 5, 2015
K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsJuly 24, 2015
K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, January 9, 2015
K140878STRAUMANN BONE LEVEL TAPERED IMPLANTAugust 20, 2014
K140737STRAUMANN CARES SCREW RETAINED BARS/BRIDGEAugust 14, 2014
K141871Straumann Bone Level NC Angled Screw Retained AbutmentsAugust 7, 2014
K133421STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD CHOPINGS,BASAL SCREWApril 17, 2014