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Dental

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

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RecordFirmDate
Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (K242360)Dent4you AG2024-11-15
Dental Glass Ceramics Blocks (HT, LT, MT) (K242407)Hunan Vsmile Biotechnology Co., Ltd.2024-11-13
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) (K240337)Guangdong Jinme Medical Technology Co., Ltd.2024-11-13
High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) (K241074)Foshan Soco Precision Instrument Co., Ltd.2024-11-12
Straumann® Anatomic Healing Abutments XC (AHA) (K241575)Straumann USA, LLC2024-11-11
TopCEM Ceramic Primer Ceramic Coupling Agent (K242749)Rizhao Huge Biomaterials Company, Ltd.2024-11-08
VioSeal (K242702)Spident Co., Ltd.2024-11-07
LL Implant System (K242379)Ossvis Co., Ltd.2024-11-07
Accelx Implant System (K242261)Biotech Dental, LLC2024-11-06
DESS Dental Smart Solutions (K242340)Terrats Medical SL2024-11-05
XERO-alpha (K242591)DRTECH Corporation2024-11-01
FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) (K242675)Spident Co., Ltd.2024-11-01
Highness Implant System (K240383)Highness Co., Ltd.2024-10-31
ZENEX Implant System_Long (K240560)Izenimplant Co., Ltd.2024-10-30
VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) (K240040)VATECH Co., Ltd.2024-10-25
ArgenZ MTZ (K242458)Argen Corporation2024-10-24
KeyPrint KeyDenture Base (K241089)Keystone Industries2024-10-24
CEREC Cercon 4D CAD/CAM Blocks (K242462)Dentsply Sirona2024-10-24
Immediate Molar Implants (K241753)Biomet 3i, LLC2024-10-23
Dynamic TiBase; TRI Screws (K241170)Talladium España, SL2024-10-21
PreXolid CAD/CAM abutments (K240725)Eclectic Co., Ltd.2024-10-18
edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK (K241131)Edelweiss Dentistry Products GmbH2024-10-18
Vittra APS Unique Flow (K232994)Dentscare Ltda2024-10-18
MP Pin flat without thread (36BMP000020/MP20) (K240321)Hager& Meisinger GmbH2024-10-17
DenMat Bulk Fill Composite (K242097)Den-Mat Holdings, LLC2024-10-15
Denture Base Resin (PN-Denture (Red, White)) (K241673)Shenzhen Piocreat 3D Technology Co., Ltd.2024-10-15
X Sensor (Model: IOS-A15IF, HDI-15DGF) (K242778)Qpix Solutions, Inc.2024-10-11
Spark™ Clear Aligner System (K240501)Ormco Corporation2024-10-11
JDZygoma dental implants (K240143)Jdentalcare Srl2024-10-11
Progressive Orthodontics App (K241153)Progressive Aligners, Inc.2024-10-11
Dental porcelain powder (K242400)Yilink (Tianjin) Biotechnology Co., Ltd.2024-10-10
BTI Interna 3.0 Dental Implant System UnicCa® (K240262)B.T.I. Biotechnology Institute, Sl.2024-10-10
TruAbutment DS; TruBase (K241485)Truabutment, Inc.2024-10-09
Jet Flow Bulk (K242014)Meta Biomed Co., Ltd.2024-10-08
Injectable Root Canal Bioceramic Sealer (i-MTA SP) (K241977)Longly Biotechnology (Wuhan) Co., Ltd.2024-10-03
Additive Manufacturing Zirconia Customized Restoration (K240586)Hangzhou Thales Medtech Co., Ltd.2024-10-03
Rest Assure System (K233497)Somnomed, Inc.2024-10-03
Ceramic Etchant (HF-5 and HF-9) (K240153)Liaoning Upcera Co., Ltd.2024-10-02
Crown HT (K242277)Sprintray, Inc.2024-10-01
LUXEN 5G (K241151)Dentalmax Co., Ltd.2024-09-30
Any-Com (K241147)Mediclus Co., Ltd.2024-09-26
Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) (K241880)Nakanishi, Inc.2024-09-20
Star E900 Handpiece Series (K240183)Dentalez, Inc., Stardental Division2024-09-19
Copra Supreme (K233064)Whitepeaks Dental Solutions GmbH2024-09-18
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment (K234142)Megagen Implant Co., Ltd.2024-09-18
Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active (K240660)Kulzer, LLC2024-09-17
KLS Martin Drill-Free MMF Screw (K233721)KLS-Martin L.P.2024-09-17
DNA Appliance (K234089)Vivos Therapeutics2024-09-16
DenQ Sub SLA Implant System (K240977)Denq2024-09-13
EK D3.3 and Ultra Wide Implants (K240232)Hiossen, Inc.2024-09-13
Elos Accurate® Hybrid Base™; Elos Accurate® Customized Abutment (K241722)Elos Medtech Pinol A/S2024-09-13
Surgikor Fixation One, Abutment Blanks and Abutments (K240803)Surgikor, LLC2024-09-12
Glidewell™ 3DP Denture Base Resin (K241493)Prismatik Dentalcraft, Inc.2024-09-12
C&B NFH Hybrid (K232559)Arum Dentistry Co., Ltd.2024-09-11
DD Hybridlayer (multicolored zirconia) (K241579)Dental Direkt GmbH2024-09-06
Luvis Chair (LC700C) (K233921)Dentis Co., Ltd.2024-09-06
ICX-Implant System (K231566)Medentis Medical GmbH2024-09-05
NextDent Jet Denture Base; NextDent Jet Denture Teeth (K241071)Vertex-Dental B.V.2024-09-04
Qraycam PRO (K221275)AIOBIO Co., Ltd.2024-09-04
Mini Screws (K231502)Proimtech Saglik Urunleri Anonim Sirketi2024-09-04
K5 (K233805)Osstem Implant Co., Ltd. Chair Business2024-09-03
Kingcera Dental Zirconia Blank (K241602)Hunan Qinghao Puzhong Technology Co., Ltd.2024-08-30
Cercon® yo ML (K241557)Dentsply Sirona2024-08-28
Vista BC Putty (K241457)Inter-Med, Inc.2024-08-28
BracePaste Fluoride Sealant (K242537)American Orthodontics Corp.2024-08-27
DESS Dental Smart Solutions (K240982)Terrats Medical SL2024-08-26
Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw (K231100)Proimtech Saglik Urunleri Anonim Sirketi2024-08-23
TDS (TECHWIN DENTAL SYSTEM) (K231932)Techwin Co., Ltd.2024-08-20
MT-Bone (K242432)Mectron S.P.A.2024-08-19
KLS Martin Oral-Max Implants MR Conditional (bundled) (K241314)KLS-Martin L.P.2024-08-16
iTero Lumina™ Pro (K240573)Align Technology , Ltd.2024-08-16
Xenograft Bovine Bone Particulate (K240133)Collagen Solutions, LLC2024-08-16
JDentalCare Dental Implant System: JDEvolution; JDEvolution plus; JDIcon; JDIcon plus (K233896)Jdentalcare Srl2024-08-16
TOV Dental Implant System (K240837)Rdj Tov Implant, Ltd.2024-08-15
The Trust (K222688)Genoss Co., Ltd.2024-08-09
OdneClean (K233844)Odne AG2024-08-08
Illusion Aligner Pro: Illusion Aligner FLX (K233356)Laxmi Dental Export Pvt., Ltd.2024-08-08
LOOP™ LED Curing Light System (CLK01) (K241238)Garrison Dental Solutions, LLC2024-08-01
Clear Moves Aligner (K241137)Clear Moves Aligners2024-08-01
LW Narrow Implant System (K233808)Ossvis Co., Ltd.2024-07-31
SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank Abutment (K240531)BioHorizons Implant Systems, Inc.2024-07-30
WERAY (K241963)Picopack Co., Ltd.2024-07-30
Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + (K240446)Shiva Products2024-07-30
Alien Aligners (K241187)Alien Milling Technologies2024-07-26
s-Clean ScanHealing Abutment (K241063)Dentis Co., Ltd.2024-07-25
Navident (K233563)Claronav, Inc.2024-07-25
Insure® Universal; Insure® Universal Automix (K240714)Cosmedent, Inc.2024-07-24
THE Graft Collagen (K230305)Purgo Biologics, Inc.2024-07-24
X-Smart Pro; X-Smart Pro+ (K233865)Dentsply Sirona, Inc.2024-07-24
K-Bond Universal (K241445)Spident Co., Ltd.2024-07-22
Premium Teeth Resin (K240538)Formlabs Ohio, Inc.2024-07-19
Papacarie Duo (K233768)Elevate Oral Care2024-07-18
Surgical Drive System (Model: ES70, ES90, E8) (K240340)Guangdong Jinme Medical Technology Co., Ltd.2024-07-18
S.I.N. Dental Implant System (K240609)S.I.N. - Sistema DE Implante Nacional S.A.2024-07-17
Light Cure Adhesive (K241056)Sincera Technology (Changchun) Co., Ltd.2024-07-16
BellaTek Bars (K241032)Biomet 3i, LLC2024-07-15
Geistlich Bio-Oss® (K240661)Geistlich Pharma AG2024-07-12
Dental Glass Ceramics Blocks (HT,LT,ST) (K241715)Aidite (Qinhuangdao) Technology Co., Ltd.2024-07-12
MRI Universal (K240651)Stryker Leibinger GmbH & Co KG2024-07-12
Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems (K240240)Prismatik Dentalcraft, Inc.2024-07-12
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