FDA.reportPublic FDA data

BIOHORIZONS IMPLANT SYSTEMS INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10608181000592496BIOHORIZONS IMPLANT SYSTEMS INC.1Y2026-01-012300 RIVERCHASE CENTER BIRMINGHAM AL US 35244

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
518011308220832K993493THE AUTOTAC SYSTEMDZL2000-01-07
518011844450069K990277O-RING ABUTMENTDZE1999-04-09
518011109251455K972313THE MAESTRO SYSTEMDZE1997-09-16
518011963466389K964330BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)DZE1997-01-17
518011725540574K960026BIOHORIZONS DENTAL IMPLANT SYSTEMDZE1996-03-28
518011820957828K951510ACE BONE SCREW TACKING KITDZL1995-08-25
518011509044802K951392MINIBONEPLATE SYSTEMJEY1995-05-05
518011030358650K260061BioHorizons CEREC Compatible Ti-BasesNHA2026-06-26
518011117772777K243521Conical Ti Base abutmentsNHA2025-05-01
518011420773923K240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentNHA2024-07-30
518011074344093K240187Tapered Pro Conical Implant SystemDZE2024-06-05
518011923539343K223697MRI compatibility for existing BioHorizons dental implants and abutmentsDZE2023-10-13
518011978656497K203252Multi-unit Abutments for CONELOGNHA2021-03-16
518011119818928K182070BioHorizons Tapered IM ImplantsDZE2018-10-10
518011803083816K180998BioHorizons CAD/CAM BarsNHA2018-09-28
518011501726697K172576BioHorizons Tapered Short ImplantsDZE2017-11-22
518011058028603K151621BioHorizons CAD/CAM AbutmentsNHA2016-01-13
518011357632988K143022BioHorizons Tapered Internal ImplantsDZE2015-01-08
518011963939976K133613INTRA-LOCK DENTAL IMPLANTSDZE2014-03-20
518011244694357K130140INTRA-LOCK OP DENTAL IMPLANTDZE2013-08-01
518011154836660K121787BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTSDZE2012-09-05
518011231246126K111199INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTSNHA2011-08-08
518011346083721K103691BIOHORIZONS ABUTMENTS FOR ZIMMERNHA2011-11-03
518011298133272K103291BIOHORIZONS LASER-LOK ABUTMENTS FOR NOBEL BIOCARENHA2011-11-04
518011507398378K103194INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOMDZE2011-04-21
518011042646344K100985BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOKNHA2010-09-09
518011853859791K093321BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEMDZE2010-04-02
518011054416844K081818BIOLOK MICRO-LOK IMPLANT SYSTEMDZE2008-11-13
518011982391774K080598MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICSNHA2008-05-21
518011641631498K080074ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XXDZE2008-02-14
518011364032372K073282BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEMDZE2008-02-15
518011162171243K073268BIOHORIZONS INTERNAL IMPLANT SYSTEMDZE2008-02-08
518012005958479K071638BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEMDZE2007-10-10
518011575072121K070601MINI DRIVE-LOCK DENTAL IMPLANT SYSTEMDZE2007-10-12
518011515585372K061567BIOHORIZONS CERAMIC ABUTMENTNHA2006-11-22
518011217369316K060267VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARELLZ2006-03-17
518011060617420K053152BIOHORIZONS SINGLE-STAGE IMPLANTDZE2005-12-02
518011807785419K053099BIOHORIZONS PLASTIC TEMPORARY ABUTMENTSNHA2006-02-14
518011877426961K052419MAXIMUS 3.0 AND OS IMPLANTSDZE2005-09-20
518011137622210K050970MILO DENTAL IMPLANT SYSTEMDZE2005-10-14
518011354922485K042429THE PRODIGY SYSTEM DENTAL IMPLANTSDZE2004-09-16
518012001616773K041938MAXIMUS OS (OVERDENTURE SYSTEM)DZE2004-07-22
518011525613192K040205INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTSNHA2004-03-22
518011521462942K032351THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANTDZE2003-10-21
518011848526574K030463MODIFICATION TO THE MAESTRO SYSTEMDZE2003-02-26
518011665634748K022795MODIFICATION TO THE MAESTRO SYSTEMNHA2002-08-30
518011754483211K022790THE AUTOTAC SYSTEM TITANIUM TACKDZL2002-08-28
518011780465607K021322ENDOSSOUS IMPLANTSDZE2002-07-24
518011701741663K020645MODIFICATION TO THE MAESTRO SYSTEMDZE2002-03-15
518011556601816K020133MODIFICATION TO THE MAESTRO SYSTEMDZE2002-01-25
518011603307646K011675THE AUTOTAC SYSTEMDZL2001-06-22
518011853528775K010458THE MAESTRO SYSTEMDZE2001-05-10
518012012078115BK120048
518011523475945
518011761911531
518011864198319
518011094165783

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE372024-06-05
NHA162026-06-26
DZL42002-08-28
LLZ12006-03-17
JEY11995-05-05