Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Dental ×
12,659 results
1057–1080 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Aug 31, 2022
MyClearALIGN Dental Aligner System
K221475 · NXC
Key Dental Technologies, LLC
Dental · 103d
Cleared Aug 31, 2022
SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
K221255 · EBF
Kerr Corporation
Dental · 121d
Cleared Aug 30, 2022
SaliPen
K220618 · QTT
Saliwell , Ltd.
Dental · 180d
Cleared Aug 30, 2022
Riva Cem Automix
K214118 · EMA
Sdi Limited
Dental · 243d
Cleared Aug 23, 2022
Bifix Hybrid Abutment Cement
K220640 · EMA
Voco GmbH
Dental · 172d
Cleared Aug 18, 2022
Bio-MEM Ti Reinforced Membrane
K210797 · NPK
B&Medi Co., Ltd.
Dental · 520d
Cleared Aug 16, 2022
G-CAM
K220329 · EBF
Graphenano Dental S.L.
Dental · 193d
Cleared Aug 16, 2022
Clear Aligner
K213026 · NXC
Shenzhen Meiming Dentistry Technology...
Dental · 329d
Cleared Aug 12, 2022
Arkligners
K220835 · NXC
Arklign Laboratories
Dental · 143d
Cleared Aug 12, 2022
Denture Base Polymers
K220680 · EBI
Shandong Huge Dental Material...
Dental · 157d
Cleared Aug 11, 2022
TERA HARZ DENTURE
K222414 · EBI
Graphy, Inc.
Dental · 1d
Cleared Aug 11, 2022
OMF ASP System
K220648 · DZJ
Vha Dean
Dental · 157d
Cleared Aug 11, 2022
KLS Martin IPS Distraction
K220050 · MQN
KLS-Martin L.P.
Dental · 217d
Cleared Aug 10, 2022
KDG Abutments
K221381 · NHA
Keystone Dental, Inc.
Dental · 89d
Cleared Aug 10, 2022
BLT Dental Implant System
K212364 · DZE
Bio Concept Co., Ltd.
Dental · 376d
Cleared Aug 09, 2022
DenMat Glutaraldehyde Desensitizer
K222357 · KLE
Denmat Holding, LLC
Dental · 5d
Cleared Aug 09, 2022
IMICRYL Composite, Composite Flow Materials
K220077 · EBF
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 211d
Cleared Aug 09, 2022
NOVA RESIN dual cure, self adhesive resin cement
K213609 · EMA
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 267d
Cleared Aug 08, 2022
Dental Impression Material
K221668 · ELW
Chemoment Materials Co.,Ltd
Dental · 61d
Cleared Aug 03, 2022
Root ZX3
K213477 · EKZ
J. Morita USA, Inc.
Dental · 278d
Cleared Aug 02, 2022
BruxZir NOW
K220816 · EIH
Prismatik Dentalcraft, Inc.
Dental · 134d
Cleared Jul 29, 2022
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K221242 · EIH
Hunan Vsmile Biotechnology Co., Ltd.
Dental · 88d
Cleared Jul 29, 2022
Dental Handpiece, Model CA160, CA160L, and CA500L
K220577 · EGS
Micro-Nx Co., Ltd.
Dental · 151d
Cleared Jul 29, 2022
NobelProcera Zirconia N1 Base
K220048 · NHA
Nobel Biocare Services AG
Dental · 204d