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
1921–1944 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Oct 26, 2018
Invisalign System with Mandibular Advancement Feature
K181739 · NXC
Align Technology, Inc.
Dental · 116d
Cleared Oct 26, 2018
Biomate Dental Implant System
K170732 · DZE
Biomate Medical Devices Technology...
Dental · 595d
Cleared Oct 22, 2018
Sonendo Material A
K181922 · KIF
Sonendo, Inc.
Dental · 96d
Cleared Oct 19, 2018
Straumann cerabone
K173594 · NPM
Institut Straumann AG
Dental · 332d
Cleared Oct 17, 2018
Ortho System
K180941 · PNN
3Shape A/S
Dental · 203d
Cleared Oct 15, 2018
BracePaste MTP Light Cure Primer
K181910 · KLE
American Orthodontics
Dental · 90d
Cleared Oct 12, 2018
Juell 3D Volo Base
K181220 · EBI
Park Dental Research Corporation
Dental · 158d
Cleared Oct 11, 2018
Ormco Spark Aligner System
K182826 · NXC
Sybron Dental Specialties
Dental · 6d
Cleared Oct 11, 2018
Sirona Dental CAD/CAM System
K181520 · NHA
Dentsply Sirona
Dental · 122d
Cleared Oct 11, 2018
Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
K180680 · LFD
Laclede, Inc.
Dental · 210d
Cleared Oct 11, 2018
OmniPore DUROMAX Surgical Implants
K180249 · JEY
Matrix Surgical Holdings, LLC/Matrix...
Dental · 255d
Cleared Oct 11, 2018
LS OIL
K173920 · EKX
J. Morita USA, Inc.
Dental · 293d
Cleared Oct 10, 2018
BioHorizons Tapered IM Implants
K182070 · DZE
BioHorizons Implant Systems, Inc.
Dental · 70d
Cleared Oct 05, 2018
Straumann SC Variobase Abutments
K173945 · NHA
Institut Straumann AG
Dental · 283d
Cleared Oct 03, 2018
IS-III active System
K181138 · DZE
Neobiotech Co., Ltd.
Dental · 156d
Cleared Sep 28, 2018
Prime&Bond active Universal Adhesive
K181476 · KLE
Dentsply Sirona
Dental · 115d
Cleared Sep 28, 2018
BioHorizons CAD/CAM Bars
K180998 · NHA
BioHorizons Implant Systems, Inc.
Dental · 165d
Cleared Sep 28, 2018
Orthocaps Twinaligner
K180241 · NXC
Ortho Caps GmbH
Dental · 242d
Cleared Sep 26, 2018
BeautiBond Universal
K180803 · KLE
Shofu Dental Corporation
Dental · 182d
Cleared Sep 19, 2018
CSM Submerged3-L Implant System
K173141 · DZE
Csm Implant
Dental · 355d
Cleared Sep 17, 2018
DenTek Ultimate Dental Guard
K180933 · OBR
Medtech Products, Inc.
Dental · 160d
Cleared Sep 13, 2018
KLS Martin Individual Patient Solutions (IPS) Planning System
K181241 · DZJ
KLS-Martin L.P.
Dental · 126d
Cleared Sep 13, 2018
HySil Impression Materials
K181236 · ELW
Osstem Implant Co., Ltd.
Dental · 126d
Cleared Sep 11, 2018
Stryker Pediatric Mandibular Distractor 2
K181504 · MQN
Stryker
Dental · 96d