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Dental

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

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RecordFirmDate
Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) (K250123)Hager& Meisinger GmbH2025-09-29
Paltop Dental Implant System (K243983)Paltop Advanced Dental Solutions, Ltd.2025-09-29
S.I.N. Dental Implant System (K251262)S.I.N. Implant System Ltda2025-09-26
JDEvolution Plus L and JDEvolution Plus LE (K251148)Jdentalcare Srl2025-09-25
Root canal repair materials (nRoot BP) (K251465)Enpuno Biotechnology Co., Ltd.2025-09-25
Digital X-Ray DentiMax Pro Imaging System (K251206)Dentimax, Inc.2025-09-24
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) (K253053)Hangzhou SHINING3D Dental Technology Co., Ltd.2025-09-23
Well-Root PT (K252285)Vericom Co., Ltd.2025-09-19
EQUIA LC ONE (K250953)GC America, Inc.2025-09-19
VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) (K251689)Nakanishi, Inc.2025-09-19
InnerView System (K251597)Perimetrics, Inc.2025-09-18
FG Bone Graft M (K244006)Full Golden Biotech Co., Ltd.2025-09-17
Double Tube Herbst Appliance (K243752)The Tmj Clinic PC2025-09-17
DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) (K252035)Kamemizu Chemical Industry Co., Ltd.2025-09-17
SFIT Abutment (K242287)Cowellmedi Co., Ltd.2025-09-16
Disposable Prophy Angle (3399-60, 3399-090, 3399-105) (K251869)Premium Plus (Dongguan) Limited2025-09-15
Nylon flexTAP(R) (K252374)Airway Technologies D/B/A Airway Management2025-09-11
Serafin® (K251758)Tns Co., Ltd.2025-09-11
Oniris; Oniris Plus (K250353)Oniris2025-09-04
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) (K251438)Guilin Woodpecker Medical Instrument Co., Ltd.2025-09-04
BruxZir® NOW (K252446)Prismatik Dentalcraft, Inc.2025-09-03
RODIN Cement (K251775)Belport Company, Inc., Gingi-Pak2025-09-02
Customized Abutment and Screw (K242768)Chengdu Besmile Medical Technology Co., Ltd.2025-09-02
Invisalign System (K252380)Align Technology, Inc.2025-08-29
G aenial Universal Injectable II (K251946)GC America, Inc.2025-08-29
FG Bone Graft B (K243745)Full Golden Biotech Corporation2025-08-29
Primescan 2 (K250771)Dentsply Sirona, Inc.2025-08-29
Additively Manufactured Aligner Resin (K251415)Aidite (Qinhuangdao) Technology Co., Ltd.2025-08-27
Motor and Apex Module (MaAM) (K251811)Dentsply Sirona, Inc.2025-08-25
NobelZygoma TiUltra Implant system (K243834)Nobel Biocare AB2025-08-25
DenMat Multilayered Zirconia Disc (K251593)Denmat Holding, LLC2025-08-25
One-Fil Putty Injectable (K251884)Mediclus Co., Ltd.2025-08-22
EnDrive (EnDriveUS) (K243692)Advanced Technology Research (A.T.R.) S.R.L.2025-08-22
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System (K251647)Dentsply Sirona, Inc.2025-08-21
IPD Dental Implant Abutments (K251471)Implant Protesis Dental 2004, S.L.2025-08-20
LOCATOR® Angled Abutment (K250721)Zest Anchors, LLC2025-08-20
Neodent Implant System - Zirconia Implant System (K250271)JJGC Indústria e Comércio de Materiais Dentários S.A.2025-08-18
Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack (K251062)Geistlich Pharma AG2025-08-14
S.I.N. Dental Implant System (K251046)S.I.N. Implant System Ltda2025-08-13
Bone Screw (K251569)Osstem Implant Co., Ltd.2025-08-13
Straumann® RidgeFit Implants (K250294)Institut Straumann AG2025-08-12
Parkell Pit and Fissure Sealant (K243254)Parkell, Inc.2025-08-08
QuickSleeper 5 (K243427)Dentalhitec2025-08-01
NUVENTUS NV.C™ Prosthetic Components (K251220)Infinitum Eta, Ltd.2025-07-28
ISO Abutment (K241183)Seum Medi Co., Ltd.2025-07-28
MIS LYNX Conical Connection Implant System (K251297)Dentsply Sirona, Inc.2025-07-24
SD TL Implant System (K250280)Arum Dentistry Co., Ltd.2025-07-23
DESS® Dental Implants (K251280)Terrats Medical SL2025-07-23
Clear Miracle (K251616)Ods Co., Ltd.2025-07-22
ELEC ENGINE (Model: ISE-170L) (K231562)Micro-Nx Co., Ltd.2025-07-18
K5 Cart, K5 Mount, K5 Swing (K251491)Osstem Implant Company., Ltd. Chair Business2025-07-17
Choice 2 DC (K250156)Bisco, Inc.2025-07-11
ResiCem EX (K251470)Shofu Dental Corporation2025-07-11
Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® (K251786)Geistlich Pharma AG2025-07-11
ARENA Star, Galaxy Star (K250063)Arum Dentistry Co., Ltd.2025-07-10
HEXIM Implant; Samwon General Abutments (K243731)P&A USA2025-07-09
URIS Long Implant & Abutments (K243255)Truabutment, Inc.2025-07-03
MTA vpt (K251390)Voco GmbH2025-07-03
USTOMED Bone Fixation/Bone Augmentation Systems - PIN (K243190)Ustomed Instrumente Ulrich Storz GmbH & Co. KG2025-06-27
T3 Pro Implants– ZimVie Packaging System (K251660)Biomet 3i, LLC2025-06-27
JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST (K250969)Dent4you AG2025-06-27
Integral Dental Unit (K243130)Guangdong Yadeng Medical Apparatus Co., Ltd.,2025-06-27
SwissGraft X (K251613)Geistlich Pharma AG2025-06-26
Sherlock (K250967)Open Implants, LLC2025-06-26
Flexible Partial Resin (K250302)Prismatik Dentalcraft, Inc.2025-06-25
MIST IC (K243009)Imagine Milling Technologies, LLC2025-06-24
TempFIT Temporary Crown and Bridge Resin (K251271)Rizhao Huge Biomaterials Company, Ltd.2025-06-23
EsCem RMGI (K250566)Spident Co., Ltd.2025-06-20
Leone Orthodontic Implant TAD (Temporary Anchorage Device) (K242944)Leone S.P.A.2025-06-19
Bioline Dental Implant System (K250872)Bioline Dental Implant Systems, Ltd.2025-06-18
Geo Abutment (K242978)Geomedi Co,., Ltd.2025-06-16
Multi M Series (K250826)Dmax Co., Ltd.2025-06-12
Injectable Root Canal Bioceramic Sealer (nRoot SP) (K250710)Enpuno Co., Ltd.2025-06-11
Once-Fil Flow (K251283)Mediclus Co., Ltd.2025-06-06
MBA Biotech Implant System (K243002)MBA Biotech Co., Ltd.2025-06-06
zirkon; structure; LFU shades, stains and glazes (K251084)Estetic Ceram AG2025-06-05
ID LIGHT CURE SYSTEM (K250804)Id Korea Co., Ltd.2025-06-04
Partial Flex (K242897)Clemde SA DE CV2025-06-03
Dynamic TiBase (K243530)Talladium España, SL2025-05-30
EsFlow PLUS (K250317)Spident Co., Ltd.2025-05-30
CERABIEN MiLai (K250673)Kuraray Noritake Dental, Inc.2025-05-29
Disposable Prophy Angle (K240950)Pacific Care Limited2025-05-28
Neodent Implant System - Custom Abutments (K250614)Jjgc Indústria E Comércia DE Materiais Dentários S.A.2025-05-27
Integral Dental Units (K242611)Mipont Medical Equipment Co., Ltd.2025-05-27
Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) (K243777)Theodent, LLC2025-05-27
BEAUTIFIL II (K251578)Shofu Dental Corporation2025-05-27
Sil-Flow (K250778)Dsi Dental Solutions, Ltd.2025-05-23
DESS Dental Smart Solutions (K250639)Terrats Medical SL2025-05-22
MEM Clear Aligner System (K242637)Mem Dental Technology Co., Ltd.2025-05-21
GrandioSO Unlimited (K251239)Voco GmbH2025-05-21
Biomic Color Opaque (K250534)Aidite (Qinhuangdao) Technology Co., Ltd.2025-05-20
FP3D (K250489)Keystone Industries2025-05-20
SleepRight Snore Aid (K250122)Splintek, Inc.2025-05-19
CeraRoot TL Implant System (TL) (K242072)Ceraroot SL2025-05-14
ZircaGlow & ZircaGlow HT Zirconia (K250393)United Zirconia2025-05-12
Reon (K250763)C.E.I.B.Med2025-05-12
turbodent touch (K251425)Mectron S.P.A.2025-05-09
Preat Abutments (K243824)Preat Corporation2025-05-08
OsseOne Dental Implant System (K233271)Synoross Dba Osseone2025-05-08
Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue (K250482)Fissiontech, LLC2025-05-08
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