FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K061397 |
ACE SURGICAL SUPPLY CO., INC. |
ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M |
08/16/2006 |
K063770 |
ALPHA-BIO TEC LTD |
ALPHA-BIO ORTHODONTIC FIXATION SCREW SYSTEM |
03/26/2007 |
K190871 |
Bio Cetec Co., Ltd. |
Bio-TackS Orthodontic Mini Implant |
01/17/2020 |
K063495 |
BIOMATERIALS KOREA INC. |
C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS |
07/26/2007 |
K111809 |
BIOMATERIALS KOREA INC. |
SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS |
09/26/2011 |
K222245 |
BioMaterials Korea, Inc |
ACR Screw System |
08/21/2023 |
K173623 |
BioMaterials Korea, Inc |
Anchor plate |
08/30/2018 |
K201919 |
Blue Sky Bio, LLC. |
Blue Sky Bio TAD |
12/17/2020 |
K202278 |
Bomei Co, Ltd. |
OBS Anchorage Screw, Biokey Anchorage Screw |
01/08/2021 |
K152297 |
BOMEI CO., LTD |
OBS Anchorage Screw |
02/09/2016 |
K113650 |
BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC |
ORTHOFIX SCREW |
10/03/2012 |
K202691 |
Craniofacial Technologies, Inc. |
Ortholock Anchorage Devices |
04/28/2022 |
K120861 |
CREEKSIDE ORTHODONTICS |
FIN-S MICROIMPLANT |
02/21/2013 |
K100633 |
D B ORTHODONTICS LTD |
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 |
04/01/2010 |
K072086 |
D B ORTHODONTICS LTD |
INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM |
10/26/2007 |
K130476 |
DENTAL MORELLI |
ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE |
01/08/2014 |
K062732 |
DENTAURUM |
TOMAS PIN 6 MM |
10/25/2006 |
K062733 |
DENTAURUM |
TOMAS PIN SD 6, 8, AND 10 MM |
11/09/2006 |
K042965 |
DENTAURUM, INC. |
TOMAS PIN |
04/15/2005 |
K181142 |
Dentos Inc |
Absoanchor Microimplant |
02/05/2019 |
K110275 |
FORESTADENT BERNHARD FORSTER GMBH |
ORTHO EASY PIN |
06/03/2011 |
K081393 |
G & H WIRE CO. |
ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW |
08/21/2008 |
K191041 |
GNI Co., LTD |
Orthodontic Fixation Screw [Smart Anchor Miniscrew] |
08/28/2020 |
K091390 |
HDC S.R.L. |
HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 |
07/30/2009 |
K060062 |
INSTITUT STRAUMANN AG |
STRAUMANN ORTHOSYSTEM |
02/03/2006 |
K161335 |
JEIL MEDICAL CORPORATION |
Dual Top Screw System |
02/23/2017 |
K102769 |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE |
02/23/2011 |
K122069 |
LANCER ORTHODONTICS, INC. |
STORM MINI SCREW |
04/11/2013 |
K071490 |
LEONE SPA |
LEONE ORTHODONTIC MINI IMPLANT |
02/22/2008 |
K073461 |
M.I.S. IMPLANTS TECHNOLOGIES LTD. |
ORTHO ANCHOR SCREWS |
01/25/2008 |
K182929 |
Microware Precision Co., Ltd. |
BIO-RAY A-1 Anchor Screw System |
11/06/2019 |
K210559 |
MK Meditech Inc. |
ATOZ Mini-Screw |
12/19/2021 |
K061266 |
ORTHO ORGANIZERS, INC. |
ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR |
07/31/2006 |
K161197 |
OSSTEM IMPLANT CO., LTD. |
Orthodontic Screw |
12/21/2016 |
K103105 |
OSSTEM IMPLANT CO.,LTD |
ORTHODONTIC SCREW |
03/25/2011 |
K211992 |
Osteonic Co., Ltd. |
Ortho MI System |
10/15/2021 |
K110392 |
PSM MEDICAL SOLUTIONS |
PSM LOMAS / BENEFIT SCREWS |
12/14/2011 |
K982509 |
STRAUMANN USA |
ORTHO IMPLANT AND ACCESSORIES |
09/30/1998 |
K061230 |
SYBRON DENTAL SPECIALTIES |
VECTORS TEMPORARY ANCHORAGE SYSTEM |
08/03/2006 |
K090476 |
SYNTEC SCIENTIFIC CORP. |
SYNTEC ORTHODONTIC MINI SCREW |
06/18/2009 |
K202790 |
Syntec Scientific Corporation |
Syntec Orthodontic Mini Screw Extended System |
09/17/2021 |
K142001 |
SYNTEC SCIENTIFIC CORPORATION - TAIPEI OFFICE |
SYNTEC WETALI ORTHODONTIC MINI SCREWS |
03/18/2015 |
K063473 |
SYNTHES (USA) |
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM |
03/08/2007 |
K093299 |
SYNTHES (USA) |
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM |
12/16/2010 |
K063149 |
T.O.A.D.S., LLC. |
ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM) |
03/08/2007 |
K040469 |
THE STRAUMANN CO. |
THE STRAUMANN ORTHO IMPLANT SYSTEM |
04/30/2004 |
K063386 |
WALTER LORENZ SURGICAL, INC. |
LORENZ ORTHODONTIC ANCHORAGE SYSTEM |
02/09/2007 |
K202163 |
Ze Fang Technology Co., Ltd. |
Mico One Orthodontic Screw |
10/07/2022 |