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Dental

12,644 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
TN-Brush (K170596)Genoss Co., Ltd.2017-09-11
Nanova Sealant (K171330)Nanova Biomaterials, Inc.2017-09-08
Implantium II (K171126)Dentium Co., Ltd.2017-09-07
Dentis Dental Implant System (K171027)Dentis Co., Ltd.2017-09-06
SHOFU MZ Primer Plus (K172106)Shofu Dental Corporation2017-08-31
NLZ Motor System (K163402)Nakanishi, Inc.2017-08-31
Internal Octa Implant System (K170031)Ebi, Inc.2017-08-31
Cortex Dental Implant System (K163385)Cortex Dental Implants Industries , Ltd.2017-08-29
Reverse Pull Adjustable Facemask (K162543)Sawbros Industries Pvt., Ltd.2017-08-28
SnoreRx (K170825)Apnea Sciences Corporation2017-08-18
Dentium NR Line CAD/CAM Abutments (K170384)Dentium Co., Ltd.2017-08-17
Clear Blue Digi LED Curing Light (K172426)Promident, LLC2017-08-16
SHOFU RESIN GLAZE (K163568)Shofu Dental Corporation2017-08-16
PANA SPRAY Plus (K163483)Nakanishi, Inc.2017-08-15
ATLANTIS suprastructures (K163398)Dentsply Sirona2017-08-14
Grandio blocs (K171200)Voco GmbH2017-08-10
Delight, Delight ortho, B&Lite S (K170529)Dentall Co., Ltd.2017-08-08
DESS Dental Smart Solutions (K170588)Terrats Medical SL2017-08-08
TruMatch CMF Titanium 3D Printed Implant System (K170272)Materialise NV2017-08-08
REVEAL Bulk (K171147)Bisco, Inc.2017-08-04
Nucleoss Tpure Implant System (K160850)Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti2017-08-04
Life Essence Universal Porcelain System (K163251)Blue Sky Bio2017-08-04
DD cubeX2 HS (K170885)Dental Direkt GmbH2017-08-01
Zirconia Dental Ceramics (K170894)Chengdu Besmile Biotechnology Co., Ltd.2017-08-01
Obturys (K170207)Itena Clinical2017-07-31
SML-OSA2 Appliances (K162816)Selane Products, Inc.2017-07-27
MagDen Dental Implant System (K162867)Shinhung Mst Co., Ltd.2017-07-26
HygePLUS Alginate Impression Material (K170812)Hygedent, Inc.2017-07-26
Custom Bars (K162633)Implant Direct Sybron Manufacturing, LLC2017-07-24
MP LeFort I Plates (K171364)Stryker2017-07-24
Demi Ultra (K163064)Kerr Corporation2017-07-18
OSSIX BONE (K163714)Datum Dental, Ltd.2017-07-18
Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) (K162856)Bonart Co., Ltd.2017-07-18
Inspire ICE aka Inspire ICE Clear Brackets (K171844)Ormco Corporation2017-07-18
CreoDent Solidex Customized Abutment and Screw (K170100)Creodent Prosthetics, Ltd.2017-07-18
Neodent Implant System - GM Line (K163194)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2017-07-14
Bonafix TWO - Dental Implant System (K162853)Bonafix Surgical and Dental Implants2017-07-14
KATANA Zirconia Block (K170986)Kuraray Noritake Dental, Inc.2017-07-13
O2Vent W (K171316)Oventus Manufacturing Pty, Ltd.2017-07-11
Anorganic Bone Mineral in Delivery Applicator (K170541)Collagen Matrix, Inc.2017-07-07
ClearPath Aligner (K162609)Clearpath Orthodontics, Ltd.2017-07-06
Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) (K162190)Villa Sistemi Medicali S.P.A.2017-07-06
TOKUYAMA CUREGRACE (K170549)Tokuyama Dental Corporation2017-07-05
SpiralTech Dental Implant System (K170372)Spiraltech Superior Dental Implants, Inc.2017-06-30
NextDent Denture, E-Denture (K162572)Vertex-Dental B.V.2017-06-30
Admira Fusion x-base (K170896)Voco GmbH2017-06-29
Spiral Shape Dental Implant System (K162299)Gp Implants2017-06-22
SIMPLANT Guide (K170849)Dentsply Sirona2017-06-15
Axiom PX (K161177)Anthogyr Sas2017-06-15
C-Line Orthodontic Ceramic Bracket (K163467)Biocetec Co., Ltd.2017-06-14
Deep Conical (DC) Implants and Accessories (K163060)Southern Implants (Pty), Ltd.2017-06-13
Intraskan DC Plus (K170967)Skanray Technologies Private Limited2017-06-08
Valiant Curing Light (K170101)Inter-Med/Vista Dental Products2017-06-08
ASD Oral Appliances (K163580)American Sleep Dentistry2017-06-08
HySil Impression Materials (K170736)Osstem Implant Co., Ltd.2017-06-07
Straumann Variobase Abutments (K170356)Institut Straumann AG2017-06-07
Straumann Variobase Abutments (K170354)Institut Straumann AG2017-06-07
Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System (K170044)Prismatik Dentalcraft, Inc.2017-06-06
APVolution System (K163228)Aesthetic-Press, LLC2017-06-05
Orthodontic Acrylic 2 (K163482)Lang Dental Manufacturing Co., Inc.2017-05-31
MIS V3 Conical Connection Dental Implant System­ (K163349)Mis Implants Technologies , Ltd.2017-05-26
AcceleDent Optima (K170093)Orthoaccel Technology, Inc.2017-05-26
Respire Pink Series with DentiTrac (K170692)Respire Medical Holding2017-05-26
TruAbutment DS (K170259)Truabutment2017-05-25
Dental Implants OKTAGON Bone Level Tapered Design (K170287)Hager& Meisinger GmbH2017-05-24
HAPI Seal (K162598)Bisco, Inc.2017-05-23
OSSTEM Implant System - Abutment (K161689)Osstem Implant Co., Ltd.2017-05-22
MRI Compatibility for Existing Zimmer Dental Implant Systems (K160398)Zimmer Dental, Inc.2017-05-17
DSM Biomedical Dental Bone Graft (K170245)Kensey Nash Corporation Dba Dsm Biomedical2017-05-16
SS SA Fixture (K163557)Osstem Implant Co., Ltd.2017-05-15
TREFOIL System (K170135)Nobel Biocare AB2017-05-11
A-dec NLZ Electric Motor System (K163131)Nakanishi, Inc.2017-05-11
Alpha Pure (K163117)Koroad America2017-05-09
Craniomaxillofacial Distraction System (CMFD) (K162594)Synthes USA Products, LLC2017-05-08
CreoDent Solidex Customized Abutment (K162734)Creodent Prosthetics, Ltd.2017-05-08
Eclipse Kiss Zirconia (K163238)Ams2017-05-04
QZA and RS Dental Implant Systems (K163640)Trinon Titanium GmbH2017-05-03
ScanX Intraoral View (K170733)Duerr Dental AG2017-05-01
Salvin Tenting Screw System (K161857)Salvin Dental Specialties2017-04-28
Insight Dental System (K170211)Insight Dental System2017-04-27
OneQ-SL s-Clean Implant System (K170220)Dentis Co., Ltd.2017-04-27
SavDenTM MTA Root Canal Filling Materials (K162661)Tyds Biotech Incorporation2017-04-25
ET US SS Prosthetic system (K160670)Osstem Implant Co., Ltd.2017-04-25
TSIII BA Fixture (K163088)Osstem Implant Co., Ltd.2017-04-21
Ortho System (K163677)3Shape A/S2017-04-20
K3 (K152830)Osstem Implant Co., Ltd.2017-04-20
CeraClean (K163171)Bisco, Inc.2017-04-14
Etgar Dental Implant System (K161743)Etgar Medical Instruments, Ltd.2017-04-14
MINNE TIES MMF Suture System (K162046)Summit Medical, Inc.2017-04-11
LED Curing Light (K152192)Monitex Industrial Co., Ltd.2017-04-07
System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight (K170731)VATECH Co., Ltd.2017-04-04
Bluephase Style 20i (K163613)Ivoclar Vivadent, AG2017-04-04
OsteoMed PINNACLE Driver (K162544)Osteomed2017-04-04
ESTELITE BULK FILL Flow (K161353)Tokuyama Dental Corporation2017-04-03
Multibase Abutments EV and ATLANTIS Suprastructures (K163350)Dentsply Sirona2017-03-31
K3PRO Konus Additional Abutments and Implants (K160581)Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG2017-03-24
PREMIUM - SHELTA Prosthetic Components (K162028)Sweden & Martina S.P.A.2017-03-24
nuance UNIVERSAL (K162967)Den-Mat Holdings, LLC2017-03-24
GuideMia Ortho+ (K162850)Guidemia Technologies, LLC2017-03-24
Bel-Cypher Pro (K163175)Takara Belmont Corporation2017-03-20
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