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
1969–1992 of 12,659
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