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
289–312 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 23, 2025
TempFIT Temporary Crown and Bridge Resin
K251271 · EBG
Rizhao Huge Biomaterials Company, Ltd.
Dental · 60d
Cleared Jun 20, 2025
EsCem RMGI
K250566 · EMA
Spident Co., Ltd.
Dental · 114d
Cleared Jun 19, 2025
Leone Orthodontic Implant TAD (Temporary Anchorage Device)
K242944 · OAT
Leone S.P.A.
Dental · 267d
Cleared Jun 18, 2025
Bioline Dental Implant System
K250872 · DZE
Bioline Dental Implant Systems, Ltd.
Dental · 86d
Cleared Jun 16, 2025
Geo Abutment
K242978 · NHA
Geomedi Co,., Ltd.
Dental · 263d
Cleared Jun 12, 2025
Multi M Series
K250826 · EIH
Dmax Co., Ltd.
Dental · 86d
Cleared Jun 11, 2025
Injectable Root Canal Bioceramic Sealer (nRoot SP)
K250710 · KIF
Enpuno Co., Ltd.
Dental · 93d
Cleared Jun 10, 2025
Dental Barrier and Sleeves
K250735 · PEM
Fomed Industries, Inc.
Dental · 91d
Cleared Jun 06, 2025
Once-Fil Flow
K251283 · EBF
Mediclus Co., Ltd.
Dental · 42d
Cleared Jun 06, 2025
MBA Biotech Implant System
K243002 · DZE
MBA Biotech Co., Ltd.
Dental · 253d
Cleared Jun 05, 2025
zirkon
K251084 · EIH
Estetic Ceram AG
Dental · 57d
Cleared Jun 04, 2025
ID LIGHT CURE SYSTEM
K250804 · EBD
Id Korea Co., Ltd.
Dental · 79d
Cleared Jun 03, 2025
Partial Flex
K242897 · EBI
Clemde SA DE CV
Dental · 253d
Cleared May 30, 2025
EsFlow PLUS
K250317 · EBF
Spident Co., Ltd.
Dental · 115d
Cleared May 30, 2025
DentalJect
K243654 · MLY
Vapocoolshot, Inc.
Dental · 185d
Cleared May 30, 2025
Dynamic TiBase
K243530 · NHA
Talladium Espa?a, SL
Dental · 197d
Cleared May 29, 2025
CERABIEN MiLai
K250673 · EIH
Kuraray Noritake Dental, Inc.
Dental · 84d
Cleared May 29, 2025
Dental Barrier and Sleeves
K250606 · PEM
Yueying Medical Instruments...
Dental · 90d
Cleared May 28, 2025
Disposable Prophy Angle
K240950 · EGS
Pacific Care Limited
Dental · 415d
Cleared May 27, 2025
BEAUTIFIL II
K251578 · EBF
Shofu Dental Corporation
Dental · 5d
Cleared May 27, 2025
Neodent Implant System - Custom Abutments
K250614 · NHA
Jjgc Ind?stria E Com?rcia DE...
Dental · 88d
Cleared May 27, 2025
Rennou™ Varnish (3% / Spearmint)
K243777 · LBH
Theodent, LLC
Dental · 169d
Cleared May 27, 2025
Integral Dental Units
K242611 · EIA
Mipont Medical Equipment Co., Ltd.
Dental · 266d
Cleared May 23, 2025
Sil-Flow
K250778 · EBF
Dsi Dental Solutions, Ltd.
Dental · 70d