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
Jul 3, 2019K180968AlphaDent Implants Dental Implants System
Alphadent Implants, Ltd., DE
DZE
Jun 17, 2019K190662MRI Compatibility for Existing Straumann Dental Implant Systems
Straumann USA, LLC
DZE
May 24, 2019K181157Conical Plus Implant System
Osseofuse International, Inc.
DZE
May 21, 2019K183242ET IV SA Dental Implants
Hiossen, Inc.
DZE
Mar 29, 2019K180924Reflect Implant System
Ids - Integrated Dental Systems
DZE
Mar 11, 2019K182313BoneTrust Implant System
Medical Instinct Deutschland GmbH, DE
DZE
Feb 21, 2019K173418NobelParallel Conical Connection
Nobel Biocare AB, SE
DZE
Feb 15, 2019K182293OsseOne Dental Implant System
Synoross Dba Osseone
DZE
Jan 24, 2019K180183Ritter Dental Implant System
Ritter Implants GmbH & Co. KG, DE
DZE
Jan 18, 2019K182620MRI Compatibility for Existing Neodent Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR
DZE
Jan 4, 2019K180477Straumann PURE Ceramic Implant System
Institut Straumann AG, CH
DZE
Dec 28, 2018K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments
Institut Straumann AG, CH
DZE
Dec 14, 2018K182194UV Active Implant System
Dio Corporation, KR
DZE
Dec 13, 2018K180859PYRAMIDION Dental Implants and Prostheses
Dentack Implants, Ltd., IL
DZE
Dec 4, 2018K183069NobelZygoma 0°
Nobel Biocare AB, SE
DZE
Nov 29, 2018K173701Implant-One System
Implant Logistics, Inc.
DZE
Nov 16, 2018K181137IT-III active System
Neobiotech Co., Ltd., KR
DZE
Nov 14, 2018K181850Inversa Implants
Southern Implants (Pty), Ltd., ZA
DZE
Nov 6, 2018K172668W Zirconia Implants
Tav Medical , Ltd., IL
DZE
Nov 1, 2018K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment System
Novodent SA, CH
DZE
Oct 26, 2018K170732Biomate Dental Implant System
Biomate Medical Devices Technology Co., Ltd., TW
DZE
Oct 10, 2018K182070BioHorizons Tapered IM Implants
BioHorizons Implant Systems, Inc.
DZE
Oct 3, 2018K181138IS-III active System
Neobiotech Co., Ltd., KR
DZE
Sep 19, 2018K173141CSM Submerged3-L Implant System
Csm Implant, KR
DZE
Sep 6, 2018K180465Provata Implant System
Southern Implants (Pty), Ltd., ZA
DZE
Aug 30, 2018K180536Neodent Implant System – GM Line
Jjgc Industria E Comercio DE Materiais Dentarios S.A., BR
DZE
Aug 17, 2018K173575OsteoReady Dental Implant System
Osteoready, LLC
DZE
Aug 17, 2018K173257BTI Dental Implant System UnicCa
B.T.I. Biotechnology Institute, Sl., ES
DZE
Aug 9, 2018K173819MyPlant II Implant System
Hager& Meisinger GmbH, DE
DZE
Aug 8, 2018K180598UNIQA Dental Implants System
Uniqa Dental, Ltd., IL
DZE
Jul 24, 2018K181178S-mini active Fixture
Neobiotech Co., Ltd., KR
DZE
Jun 30, 2018K171197Zuga Dental Implant System
Zuga Medical, Inc.
DZE
Jun 28, 2018K173116KJ ZIRCONIA Implant System
Kj Meditech Co., Ltd., KR
DZE
Jun 22, 2018K180282MIS Internal Hex Dental Implant System
Mis Implants Technologies , Ltd., IL
DZE
Jun 18, 2018K172345IU Implant System
Warantec Co., Ltd., KR
DZE
Jun 11, 2018K172821Ti-one 101 TS Dental Implant System
Hung Chun Bio-S Co., Ltd., TW
DZE
Jun 8, 2018K173706Piccolo Implants and Accessories
Southern Implants (Pty), Ltd., ZA
DZE
Jun 5, 2018K173961Straumann BLX Implant System
Institut Straumann AG, CH
DZE
Jun 1, 2018K173975UF(II) Wide Fixture
Dio Corporation, KR
DZE
May 24, 2018K173938IS-III HActive Fixture
Neobiotech Co., Ltd., KR
DZE
May 10, 2018K180360OKTAGON Implant System
Hager& Meisinger GmbH, DE
DZE
May 4, 2018K172100URIS OMNI System
Truabutment, Inc.
DZE
Apr 10, 2018K170776DTI-1 SLA IMPLANT SYSTEM
Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi, TR
DZE
Apr 5, 2018K173207SIC invent Dental Implant Systems
Sic Invent AG, CH
DZE
Apr 3, 2018K172630Kisses Plus Implant System
Achimhai Medical Corporation, KR
DZE
Mar 30, 2018K170608UF(II) Implant System
Dio Corporation, KR
DZE
Feb 27, 2018K173343Zygomatic Implant System
Southern Implants (Pty), Ltd., ZA
DZE
Feb 10, 2018K170131TAV Medical Dental Implants System
Tav Medical , Ltd., IL
DZE
Feb 9, 2018K171179BR Type Implant System
Biotem Co., Ltd., KR
DZE
Jan 31, 2018K172240SPI Dental Implant System
Msi France, FR
DZE

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