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
1441–1464 of 12,611
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