Medical Device Manufacturer · US , Waltham , MA

Straumann USA

41 submissions · 41 cleared · Since 1996
41
Total
41
Cleared
0
Denied

Straumann USA — FDA 510(k) Submissions

Straumann USA has submitted 41 FDA 510(k) premarket notifications since 1996, of which 41 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Implant, Endosseous, Root-form, Abutment, Implant, Dental, Endosseous, System, Image Processing, Radiological, Implant, Endosseous, Orthodontic, Prosthesis, Breast, External, Used With Adhesive . Use the specialty filter in the sidebar to narrow results.

41 devices
1–25 of 41
PURE Ceramic Implants
K151328 · DZE Implant, Endosseous,... · Dental
Jan 2016 238d
CODIAGNOSTIX IMPLANT PLANNING SOFTWARE
K130724 · LLZ System, Image Processing,... · Radiology
Jun 2013 102d
STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS
K130808 · NHA Abutment, Implant,... · Dental
Jun 2013 95d
TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS
K122855 · DZE Implant, Endosseous,... · Dental
Dec 2012 85d
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
K121131 · DZE Implant, Endosseous,... · Dental
Jun 2012 54d
NNC GOLD ABUTMENT FOR BRIDGES
K113606 · NHA Abutment, Implant,... · Dental
Jan 2012 52d
NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT
K113410 · NHA Abutment, Implant,... · Dental
Jan 2012 56d
NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS
K113283 · NHA Abutment, Implant,... · Dental
Dec 2011 51d
STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM
K112280 · NHA Abutment, Implant,... · Dental
Nov 2011 99d
STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
K111357 · DZE Implant, Endosseous,... · Dental
Oct 2011 140d
STRAUMANN TIBRUSH
K111724 · ELB Scaler, Rotary · Dental
Sep 2011 84d
NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
K110580 · NHA Abutment, Implant,... · Dental
Aug 2011 164d
STRAUMANN RC TEMPORARY ABUTMENTS
K093027 · DZE Implant, Endosseous,... · Dental
Feb 2010 136d
STRAUMANN DENTAL IMPLANT SYSTEM
K083550 · DZE Implant, Endosseous,... · Dental
Feb 2009 87d
STRAUMANN GUIDED INSTRUMENTS
K082532 · DZI Drill, Bone, Powered · Dental
Oct 2008 49d
CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS
K080286 · NHA Abutment, Implant,... · Dental
Mar 2008 32d
SYNOCTA ABUTMENTS
K073628 · NHA Abutment, Implant,... · Dental
Jan 2008 27d
STRAUMANN P.004 RC GOLD ABUTMENT FOR BRIDGES
K071888 · NHA Abutment, Implant,... · Dental
Oct 2007 98d
P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS
K072151 · NHA Abutment, Implant,... · Dental
Sep 2007 39d
P.004 HEALING ABUTMENTS AND CLOSURE SCREWS
K071585 · NHA Abutment, Implant,... · Dental
Jul 2007 30d
WN SYNOCTA GOLD ABUTMENT
K063789 · NHA Abutment, Implant,... · Dental
May 2007 140d
STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING
K061277 · NHA Abutment, Implant,... · Dental
Apr 2007 339d
STRAUMANN PREFGEL
K063812 · KJJ Cleanser, Root Canal · Dental
Jan 2007 21d
STRAUMANN NARROW NECK IMPLANTS
K060958 · DZE Implant, Endosseous,... · Dental
Aug 2006 139d
STRAUMANN COMPUTER AIDED RESTORATION SERVICE
K052272 · NHA Abutment, Implant,... · Dental
Jan 2006 134d
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