ClearanceBrief
Panels › Dental › Product code DZE · Class 2

Implant, Endosseous, Root-Form

Regulation 872.3640

19510(k)s in 12 months (1,550 all time)
2recalls in 12 months (212 all time)
192recalls that name a 510(k)
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Top companies in DZE

Company510(k)sRecalls
Nobel Biocare AB3337
Biomet 3i1152
Nobelpharma AB520
Zimmer Dental, Inc.1930
Straumann USA359
Implant Innovations, Inc.374
Steri-Oss, Inc.400
BioHorizons Implant Systems, Inc.2612
Minimatic Implant Technology340
Implant Center of the Palm Beaches320
Decided510(k)Device and applicantCode
Nov 13, 2008K081818BIOLOK MICRO-LOK IMPLANT SYSTEM
BioHorizons Implant Systems, Inc.
DZE
Nov 7, 2008K081806IDI IMPLANT SYSTEM
Idi Biomedical, LLC
DZE
Nov 7, 2008K081128MOLAR IMPLANT
Nobel Biocare AB
DZE
Oct 24, 2008K081900TEMPORARY TOOTH REPLACEMENT
Ormco Corp.
DZE
Oct 21, 2008K073645SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM
659543 BC , Ltd., CA
DZE
Oct 14, 2008K082213GS III FIXTURE SYSTEM
Osstem Implant Co., Ltd.
DZE
Oct 10, 2008K0733685.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT
Bicon, LLC
DZE
Oct 9, 2008K080559DIO SM IMPLANT SYSTEM
Dsi, Inc.
DZE
Sep 19, 2008K081653MDI MII ONE-PIECE IMPLANT, 2.9MM
Imtec Corp.
DZE
Sep 17, 2008K081579INVENTUS IMPLANT SYSTEM
Inventus Co., Ltd., CA
DZE
Sep 17, 2008K080156OSSEOSPEED TM PROFILE SYSTEM
Astra Tech AB
DZE
Sep 12, 2008K081226SIMPACT IMPLANT SYSTEM
Simpact, LLC
DZE
Sep 5, 2008K071803ARDS DENTAL IMPLANTS
Ards, Ltd.
DZE
Sep 3, 2008K080594MS SYSTEM (NARROW RIDGE)
Osstem Implant Co., Ltd.
DZE
Aug 15, 2008K081302RESCUE EXTERNAL IMPLANT SYSTEM
Megagen Implant Co., Ltd.
DZE
Jul 17, 2008K080744HG II FIXTURE SYSTEM
Osstem Implant Co., Ltd.
DZE
Jul 15, 2008K081078NT/IT SYSTEM
Osstem Implant Co., Ltd.
DZE
Jul 15, 2008K080633SCREWINDIRECT DENTAL IMPLANTS
Implant Direct, LLC
DZE
Jul 3, 2008K080224KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK
SOADCO, S.L., AD
DZE
May 30, 2008K080129SECURE IMPLANT SYSTEM (2.5/3.0MM)
Dio Department Dsi, Inc.
DZE
May 30, 2008K080115I-MINI DENTAL IMPLANT
Oco Biomedical
DZE
May 16, 2008K080713REACTIVE DENTAL IMPLANT SYSTEM
Implant Direct, LLC
DZE
May 16, 2008K073070DIO BIOTITE-H IMPLANT SYSTEM
Dio Department Dsi, Inc.
DZE
May 14, 2008K080128SM-EXTRA WIDE (RBM) IMPLANT SYSTEM
Dio Department Dsi, Inc.
DZE
May 14, 2008K073622EASY GRIP DENTAL IMPLANT SYSTEM
T.F.I. System S.R.L, IT
DZE
May 9, 2008K072595OMNI-TIGHT
Basic Dental Implant Systems, Inc.
DZE
Apr 30, 2008K080396OSSEOSPEED NARROW
Astra Tech AB
DZE
Apr 22, 2008K080162UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT
Mis Implants Technologies , Ltd., IL
DZE
Apr 15, 2008K070570DIO IMPLANT SYSTEM
Dio Department Dsi, Inc.
DZE
Apr 11, 2008K080126DIO PROTEM IMPLANT SYSTEM
Dio Department Dsi, Inc.
DZE
Apr 11, 2008K073058RESCUE INTERNAL IMPLANT SYSTEM
Megagen Co., Ltd.
DZE
Apr 7, 2008K073465US/GS ULTRA WIDE SYSTEM
Osstem Implant Co., Ltd.
DZE
Apr 4, 2008K073486DENTIS DENTAL IMPLANT SYSTEM
Dentis Co., Ltd.
DZE
Apr 4, 2008K073458BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2)
Btlock Srl, IT
DZE
Mar 31, 2008K073075FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS
Dentsply International, Inc.
DZE
Mar 28, 2008K073713BLUE SKY BIO DENTAL IMPLANT SYSTEM
Blue Sky Bio, LLC
DZE
Mar 24, 2008K070184DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT
Ospol AB, SE
DZE
Mar 13, 2008K073343ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XX
Ace Surgical Supply Co., Inc.
DZE
Mar 10, 2008K072425JNE IMPLANT SYSTEM
GC America, Inc.
DZE
Mar 7, 2008K080387HU II / HS II FIXTURE SYSTEM
Osstem Implant Co., Ltd.
DZE
Mar 7, 2008K073247US/SS/GS SYSTEM
Osstem Implant Co., Ltd.
DZE
Mar 7, 2008K073161REPLUS DENTAL IMPLANTS (HA)
Implant Direct, LLC
DZE
Feb 28, 2008K073116EBI INTERNAL IMPLANT SYSTEM
Ebi, Inc.
DZE
Feb 15, 2008K073282BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM
BioHorizons Implant Systems, Inc.
DZE
Feb 15, 2008K073067ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS
Dentsply International, Inc.
DZE
Feb 15, 2008K072447PENTABORN
Mediscitec, Inc.
DZE
Feb 14, 2008K080074ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
Ace Surgical Supply Co., Inc.
DZE
Feb 8, 2008K073268BIOHORIZONS INTERNAL IMPLANT SYSTEM
BioHorizons Implant Systems, Inc.
DZE
Feb 6, 2008K071148ATLAS IMPLANT SYSTEM
Cowellmedi Co., Ltd.
DZE
Feb 4, 2008K072959MS SYSTEM (DENTURE)
Osstem Implant Co., Ltd.
DZE

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