Medical Device Manufacturer · US , Andover , MA

Straumann USA, LLC - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 2012
24
Total
24
Cleared
0
Denied

Straumann USA, LLC has 24 FDA 510(k) cleared dental devices. Based in Andover, US.

Latest FDA clearance: Nov 2024. Active since 2012.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Straumann USA, Lls as regulatory consultant.

FDA 510(k) Regulatory Record - Straumann USA, LLC
24 devices
1-24 of 24
Cleared Nov 11, 2024
Straumann® Anatomic Healing Abutments XC (AHA)
K241575 · NHA
Dental · 161d
Cleared Jul 29, 2021
Straumann Surgical Cassettes
K203753 · KCT
General Hospital · 218d
Cleared Feb 08, 2021
Straumann 4 mm Short Implants
K202942 · DZE
Dental · 131d
Cleared Apr 06, 2020
Straumann Screw-Retained Abutments
K192401 · NHA
Dental · 216d
Cleared Jun 17, 2019
MRI Compatibility for Existing Straumann Dental Implant Systems
K190662 · DZE
Dental · 94d
Cleared Jan 19, 2018
Straumann Dental Implant System
K171784 · DZE
Dental · 218d
Cleared Mar 08, 2017
BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing...
K162890 · DZE
Dental · 142d
Cleared Mar 04, 2016
Straumann RN Gold Abutment for Bridge
K151590 · NHA
Dental · 266d
Cleared Sep 16, 2015
Straumann CARES Titanium Alloy (TAN) Abutment
K150899 · NHA
Dental · 166d
Cleared Sep 11, 2015
Straumann Variobase for CEREC
K151324 · NHA
Dental · 116d
Cleared Aug 10, 2015
Straumann Screw-Retained Abutment
K150814 · NHA
Dental · 136d
Cleared Aug 10, 2015
NC Straumann Screw Retained Abutments
K151247 · NHA
Dental · 91d
Cleared Aug 05, 2015
NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase...
K151157 · NHA
Dental · 96d
Cleared Jul 24, 2015
Straumann® Dental Implant System ¿ Roxolid® SLA Implants
K150938 · DZE
Dental · 108d
Cleared Jan 09, 2015
Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann...
K142890 · NHA
Dental · 98d
Cleared Aug 20, 2014
STRAUMANN BONE LEVEL TAPERED IMPLANT
K140878 · DZE
Dental · 135d
Cleared Aug 14, 2014
STRAUMANN CARES SCREW RETAINED BARS/BRIDGE
K140737 · NHA
Dental · 143d
Cleared Aug 07, 2014
Straumann Bone Level NC Angled Screw Retained Abutments
K141871 · NHA
Dental · 27d
Cleared Apr 17, 2014
STRAUMANN MAGELLAN(TM) ABUTMENT,PROTECTIVE CAP,TITANIUM COPINGS,GOLD...
K133421 · NHA
Dental · 160d
Cleared Feb 21, 2014
STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT...
K132219 · NHA
Dental · 219d
Cleared Jan 15, 2014
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL...
K132844 · NHA
Dental · 126d
Cleared Apr 29, 2013
STRAUMANN DENTAL IMPLANT SYSTEM
K130222 · DZE
Dental · 90d
Cleared Apr 10, 2013
STRAUMANN DENTAL IMPLANT SYSTEM
K123784 · DZE
Dental · 121d
Cleared Nov 02, 2012
NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA...
K122192 · NHA
Dental · 101d
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