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
1489–1512 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Oct 07, 2020
Abutment Design
K200100 · PNP
3Shape A/S
Dental · 265d
Cleared Oct 05, 2020
Membrane Screws and Membrane Tacks
K201561 · DZL
Neoss Limited
Dental · 117d
Cleared Oct 02, 2020
OsOpia Synthetic Bone Void Filler
K201546 · LYC
Revisios BV
Dental · 115d
Cleared Oct 02, 2020
Encore System
K201238 · ORY
Siesta Medical, Inc.
Dental · 148d
Cleared Oct 02, 2020
BZF-29
K200682 · KLE
GC America, Inc.
Dental · 200d
Cleared Oct 02, 2020
OssGuide
K200623 · NPL
Sk Bioland Co., Ltd.
Dental · 207d
Cleared Oct 02, 2020
Slow Wave DS8
K191320 · LQZ
Slow Wave, Inc.
Dental · 506d
Cleared Sep 29, 2020
Dual Cure Resin Cement
K201790 · EMA
Rizhao Huge Biomaterials Company, Ltd.
Dental · 91d
Cleared Sep 29, 2020
Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants
K193401 · DZE
Altatec GmbH
Dental · 298d
Cleared Sep 28, 2020
Eon Aligner
K202685 · NXC
Eon Dental Jordan, LLC
Dental · 13d
Cleared Sep 28, 2020
Transcend
K201795 · EBF
Ultradent Product, Inc.
Dental · 90d
Cleared Sep 25, 2020
Honorst Implant System
K202039 · DZE
Medimecca Co., Ltd.
Dental · 64d
Cleared Sep 25, 2020
Light Cure Dental Adhesive
K201787 · KLE
Rizhao Huge Biomaterials Company, Ltd.
Dental · 87d
Cleared Sep 24, 2020
A-Silicone for Bite Registration
K201684 · ELW
Shandong Huge Dental Material...
Dental · 94d
Cleared Sep 24, 2020
Straumann BoneCeramic
K201051 · LYC
Institut Straumann AG
Dental · 156d
Cleared Sep 23, 2020
IBS Implant System
K202479 · DZE
Innobiosurg Co., Ltd.
Dental · 26d
Cleared Sep 18, 2020
DIA-ROOT BIO MTA
K200174 · KIF
DiaDent Group International
Dental · 239d
Not Cleared Sep 17, 2020
ToothWave™
DEN190039 · QMJ
Home Skinovations , Ltd.
Dental · 392d
Cleared Sep 11, 2020
Porcine Mineral Collagen Composite Moldable
K201859 · NPM
Collagen Matrix, Inc.
Dental · 67d
Cleared Sep 10, 2020
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
K201944 · JEY
Synthes USA Products, LLC
Dental · 59d
Cleared Sep 10, 2020
Straight T Clear Dental Aligner
K201450 · NXC
Straight T, Inc.
Dental · 101d
Cleared Sep 10, 2020
DSM Biomedical Dental Bone Graft Plus
K193212 · NPM
Dsm Biomedical
Dental · 294d
Cleared Sep 09, 2020
Structur CAD
K201090 · EBG
Voco GmbH
Dental · 139d
Cleared Sep 09, 2020
Vista Rinse, Vista Rinse Plus
K193409 · KJJ
Inter-Med/Vista Dental Products
Dental · 275d