FDA 510(k) Applications Submitted by Christopher Klaczyk
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220140 |
01/18/2022 |
ClearCorrect System |
ClearCorrect, LLC |
| K070300 |
01/31/2007 |
EXPEDIUM SFX CROSS CONNECTOR SYSTEM |
DEPUY SPINE, INC. |
| K090242 |
02/02/2009 |
GAMMA-BSM, BETA-BSM |
ETEX CORP. |
| K160262 |
02/02/2016 |
n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, |
Institut Straumann AG |
| K210320 |
02/04/2021 |
ClearCorrect System |
ClearCorrect LLC |
| K080313 |
02/06/2008 |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K090310 |
02/06/2009 |
EQUIVABONE |
ETEX CORP. |
| K170356 |
02/06/2017 |
Straumann Variobase Abutments |
Institut Straumann AG |
| K170354 |
02/06/2017 |
Straumann Variobase Abutments |
Institut Straumann AG |
| K070387 |
02/09/2007 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K170420 |
02/13/2017 |
n!ce Glass Ceramic Blocks for Amann Girrbach |
Institut Straumann AG |
| K140737 |
03/24/2014 |
STRAUMANN CARES SCREW RETAINED BARS/BRIDGE |
STRAUMANN USA, LLC |
| K090855 |
03/30/2009 |
EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE |
ETEX CORP. |
| K100883 |
03/30/2010 |
CARRIGEN |
ETEX CORP. |
| K150899 |
04/03/2015 |
Straumann CARES Titanium Alloy (TAN) Abutment |
STRAUMANN USA, LLC |
| K140878 |
04/07/2014 |
STRAUMANN BONE LEVEL TAPERED IMPLANT |
STRAUMANN USA, LLC |
| K150938 |
04/07/2015 |
Straumann« Dental Implant System ┐ Roxolid« SLA Implants |
STRAUMANN USA, LLC |
| K151157 |
05/01/2015 |
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 |
STRAUMANN USA, LLC |
| K081252 |
05/02/2008 |
EXPEDIUM 4.5MM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K151247 |
05/11/2015 |
NC Straumann Screw Retained Abutments |
STRAUMANN USA, LLC |
| K151324 |
05/18/2015 |
Straumann Variobase for CEREC |
STRAUMANN USA, LLC |
| K071495 |
05/31/2007 |
EXPEDIUM 4.5MM SPINE SYSTEM |
DEPUY SPINE, A JOHNSON & JOHNSON COMPANY |
| K091607 |
06/03/2009 |
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE |
ETEX CORP. |
| K101557 |
06/04/2010 |
GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN |
ETEX CORP. |
| K091729 |
06/11/2009 |
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE |
ETEX CORP. |
| K151590 |
06/12/2015 |
Straumann RN Gold Abutment for Bridge |
STRAUMANN USA, LLC |
| K161677 |
06/17/2016 |
Straumann Sterile Healing Solution |
Institut Straumann AG |
| K081898 |
07/03/2008 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K071860 |
07/05/2007 |
MODIFICATION TO: VIPER SPINE SYSTEM |
DEPUY SPINE, INC. |
| K141871 |
07/11/2014 |
Straumann Bone Level NC Angled Screw Retained Abutments |
STRAUMANN USA, LLC |
| K052158 |
08/09/2005 |
WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE |
WELCH ALLYN, INC. |
| K162311 |
08/18/2016 |
Straumann PrefGel |
INSTITUT STRAUMANN AG |
| K132844 |
09/11/2013 |
STRAUMANN CARES BONE LEVEL SCREW RETAINED BARS, STRAUMANN CARES BONE LEVEL SCREW RETAINED BRIDGES |
STRAUMANN USA, LLC |
| K102812 |
09/28/2010 |
GAMMA-BSM; BETA-BSM; EQUIVABONE |
ETEX CORPORATION |
| K162848 |
10/11/2016 |
Straumann CARES Golden Ti/TiN Abutments |
INSTITUT STRAUMANN AG |
| K063156 |
10/17/2006 |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K093447 |
11/05/2009 |
CARRIGEN |
ETEX CORP. |
| K073126 |
11/06/2007 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K173562 |
11/17/2017 |
Straumann Jason Membrane |
Institut Straumann AG |
| K133592 |
11/22/2013 |
NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM |
NEODENT USA, INC. |
| K073364 |
11/30/2007 |
EXPEDIUM 4.5MM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K063741 |
12/18/2006 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K073562 |
12/19/2007 |
MODIFICATION TO VIPER SPINE SYSTEM |
DEPUY SPINE, INC. |
| K063772 |
12/21/2006 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
| K173945 |
12/26/2017 |
Straumann SC Variobase Abutments |
Institut Straumann AG |
| K153758 |
12/30/2015 |
Straumann Bone Level Tapered Implants |
INSTITUT STRAUMANN AG |
| K050074 |
01/12/2005 |
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 |
WELCH ALLYN, INC. |
| K040232 |
02/02/2004 |
LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999 |
LSI SOLUTIONS |
| K031443 |
05/06/2003 |
LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS |
LSI SOLUTIONS |
| K024301 |
12/24/2002 |
LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT |
LSI SOLUTIONS |
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