FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,611 results
1009–1032 of 12,611
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