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Dental

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

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RecordFirmDate
BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants (K212533)Institut Straumann AG2022-01-28
STEP-1 PumEtch (K213093)Rounding Third, LLC2022-01-28
Elevo Snoring Intervention Set (K213475)Zelegent, Inc.2022-01-27
INNO SLA Submerged Implant System (K201323)Cowellmedi Co., Ltd.2022-01-25
HDH Treatment Planning System (K212173)Cdb Corporation2022-01-25
Saremco Print CROWNTEC (K213343)Saremco Dental AG2022-01-21
Parkell Self-Adhesive Cement (K210259)Parkell, Inc.2022-01-20
Franz Zirconia Dental Crown (K203072)Franz Biotech, Inc.2022-01-19
Precision Align (K212772)Precision Align, LLC2022-01-15
UltraPrint-Dental Temp C&B UV (K213643)Guangzhou Heygears IMC., Inc.2022-01-14
Dental Electric Motor (K203706)Guilin Woodpecker Medical Instrument Co., Ltd.2022-01-13
PRESIDENT The Original (K220097)Coltène/Whaledent AG2022-01-13
High Retention Attachment System (K213391)Zest Anchors, LLC2022-01-11
3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix (K212541)Deltamed GmbH2022-01-10
CORE1 Implant System (K210039)Cybermed, Inc.2022-01-07
EK Implants and Abutments System (K203360)Hiossen, Inc.2022-01-07
Dental Zirconia Ceramic (K213570)Aidite (Qinhuangdao) Technology Co., Ltd.2022-01-07
Jplant (K211978)Jj Medical Co., Ltd.2022-01-05
Encore System (K213159)Siesta Medical, Inc.2021-12-22
Neocis Guidance System (NGS) with Yomi Plan v2.0.1 (K210711)Neocis, Inc.2021-12-22
BellaTek Encode Emergence Healing Abutments (K212730)Biomet 3i, LLC2021-12-21
TRI-matrix Implant Line (K203660)Tri Dental Implants Int. AG2021-12-21
Vision (K212770)Softsmile, Inc.2021-12-21
SURGmatic S15 L Pro (K213139)Kavo Dental GmbH2021-12-21
N1 TiUltra TCC Implant System (K211109)Nobel Biocare Services AG2021-12-21
ATOZ Mini-Screw (K210559)Mk Meditech, Inc.2021-12-19
Cordless Prophy System, Model: i-Polish (K211531)Guilin Woodpecker Medical Instrument Co., Ltd.2021-12-17
ArchForm Orthodontic Software System (K213916)Archform, Inc.2021-12-16
DESS Dental Implants (K212538)Terrats Medical SL2021-12-14
Dental Scaler and Air Polisher (K203615)Guilin Woodpecker Medical Instrument Co., Ltd.2021-12-10
DESS Dental Smart Solutions (K212577)Terrats Medical SL2021-12-10
JAZZ Solo sensor (K213637)Jazz Imaging, LLC Dba Jazz Imaging2021-12-10
C&B 5.0 Hybrid (K210817)Arum Dentistry Co., Ltd.2021-12-08
Injectable Root Canal Bioceramic Sealer (K212983)Beijing C-Root Dental Medical Devices Co., Ltd.2021-12-08
3Delta Crown (K211804)Deltamed GmbH2021-12-06
LUXEN CL Dental Liquid (K212548)Dentalmax Co., Ltd.2021-12-06
PS System (K211721)Inter-Med, Inc.2021-12-02
Paltop Narrow Implant (K210117)Paltop Advanced Dental Solutions, Ltd.2021-11-30
Sherlock (K212664)Open Implants, LLC2021-11-30
C-30 Crown Kit (K211345)Perfect Fit Crowns, LLC2021-11-24
VITA Akzent LC (K211854)Vita Zahnfabrik GmbH H Rauter & CO2021-11-22
FAICO Dental Implant System and CAD/CAM Abutments (K211871)Faico Medical, LLC2021-11-18
BruxZir Esthetic (K213425)Prismatik Dentalcraft, Inc.2021-11-17
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K212765)Bloomden Bioceramics (HuNan) Co., Ltd.2021-11-15
DS Implants abutments provided with the EV connection (K213449)Dentsply Sirona2021-11-15
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K212259)Zirdent New Material Co., Ltd.2021-11-12
Highspeed Airturbine Handpiece (K202371)Beijing Dongbo Dental Handpiece Co., Ltd.2021-11-08
Ortho Aligner System (K212496)Ortho Lab Services, LLC2021-11-04
Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) (K210473)Imicryl Dis Malzemeleri Sanayi VE Ticaret AS2021-11-02
Alpha Dent Implants Dental Implants System (K210499)Alpha Dent Implants GmbH2021-11-01
EndSnorZ Sleep Appliance (K211069)Prismatik Dentalcraft, Inc.2021-10-26
QuickAligners (K211537)Oral Image, Inc.2021-10-26
S.I.N. Dental Implant System (K211921)S.I.N. - Sistema DE Implante Nacional S.A.2021-10-20
Multi-unit Abutment, Multi-unit Angled Abutment (K203808)Megagen Implant Co., Ltd.2021-10-20
Magicore System (K212517)Innobiosurg Co., Ltd.2021-10-15
Ortho MI System (K211992)Osteonic Co., Ltd.2021-10-15
Vittra APS Unique (K210231)Dentscare Ltda2021-10-14
UltraCal XS (K211905)Ultradent Products, Inc.2021-10-13
Straumann CARES P-Series CAD/CAM System (K203750)Institut Straumann AG2021-10-09
Clear Aligner (K203688)Wuxi EA Medical Instruments Technologies Limited.2021-10-08
The Micro Screw System, Micro Screw System Basic (K201210)Hager& Meisinger GmbH2021-10-08
Digital Intraoral X-ray Imaging System (K212279)Iray Technology Taicang , Ltd.2021-10-07
TrusFIL Universal Composite Restorative (K202063)Rizhao Huge Biomaterials Company, Ltd.2021-10-06
INNI-CERA (K211308)Aon Co., Ltd.2021-10-04
BRIUS Planner Software (K212828)Brius Technologies, Inc.2021-10-01
Implanova (K210523)Dental Evolutions, Inc.2021-09-30
Inman Digital Clear Aligners (K210763)Inman Orthodontic Laboratories, Inc.2021-09-29
Imaging Plate Scanner, i-Scan (K212080)Guilin Woodpecker Medical Instrument Co., Ltd.2021-09-27
Dynamic TiBase (K212108)Talladium España, SL2021-09-24
Nobel Biocare Dental Implant Systems Portfolio - MR Conditional (K212125)Nobel Biocare AG2021-09-24
ABC Dental Implant System (K202092)Abracadabra Implants , Ltd.2021-09-23
Smylio Invisible Clear Aligners (K212660)Smylio, Inc.2021-09-22
ACTIVA PRESTO PACK (K210045)Pulpdent Corporation2021-09-22
SMILERS (K212961)Biotech Dental Smilers, Sas2021-09-20
Syntec Orthodontic Mini Screw Extended System (K202790)Syntec Scientific Corporation2021-09-17
BioRoot Flow 0.5g, BioRoot Flow 2g (K212283)Septodont2021-09-16
TruAbutment DS, TruBase (K203649)Truabutment, Inc.2021-09-15
RXS 1000 (K202369)Rolence Enterprise, Inc.2021-09-15
s-Clean Pre-Milled Abutment Mini (K210410)Dentis Co., Ltd.2021-09-10
Dental Low-speed Handpieces and Accessories (K202786)Microp Technology (Taiwan), Inc.2021-09-03
StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 (K212103)Fona S.R.L2021-08-30
AnyOne External Implant System (K203554)Megagen Implant Co., Ltd.2021-08-28
Clear Aligners (K210373)Shenzhen Yinuo Dental Technology Co.Ltd2021-08-27
Sonendo Filling Material 5C (K211995)Sonendo, Inc.2021-08-27
PrimeTaper EV Dental Implant (K210610)Dentsply Sirona, Inc.2021-08-27
Amber Mill Q Series & Amber Mill Direct Series (K202952)Hass Corp.2021-08-26
Premilled Titanium Block System (K203344)Innobiosurg Co., Ltd.2021-08-25
SmartGuard Anti-Snoring Device (K200657)Smartguard Rx, Inc.2021-08-23
IPS e.max One (K211916)Ivoclar Vivadent, AG2021-08-20
Wishbone HA (K211551)Wishbone SA2021-08-20
Oral Surgery Contra (K211584)Nakanishi, Inc.2021-08-19
s-Clean Pre-Milled Abutment (K210362)Dentis Co., Ltd.2021-08-19
mmRNA appliance (K210203)Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)2021-08-19
White Endoseal MTA (K212229)Maruchi2021-08-13
Neodent Implant System - Zirconia Implant System (K210336)Jjgc Industria E Comercio DE Materiais Dentarios S.A.2021-08-13
Biodentine XP 500, Biodentine XP 200 (K211799)Septodont2021-08-10
Kisses Plus Implant System (K200193)Achimhai Medical Corporation2021-08-06
ClearCorrect System (K210320)Clearcorrect, LLC2021-08-06
Biomet Microfixation OmniMax MMF System (K202969)Biomet Microfixation2021-08-05
DESS Dental Smart Solutions (K203464)Terrats Medical SL2021-08-04
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