FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,595 results
529–552 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jun 21, 2024
rainbow Paste Stain SE
K233885 · EIH
Genoss Co., Ltd.
Dental · 196d
Cleared Jun 20, 2024
RODIN Titan 3D Resin
K240688 · EBI
Belport Company, Inc., Gingi-Pak
Dental · 99d
Cleared Jun 20, 2024
Copra Smile, Copra Supreme Hyperion
K233158 · EIH
Whitepeaks Dental Solutions GmbH
Dental · 267d
Cleared Jun 20, 2024
Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
K233117 · EBW
Nakanishi, Inc.
Dental · 267d
Cleared Jun 18, 2024
Invisalign System
K241412 · NXC
Align Technology, Inc.
Dental · 32d
Cleared Jun 13, 2024
ProMin Dental Desensitizing Gel
K231060 · LBH
Belport Company, Inc., Gingi-Pak
Dental · 427d
Cleared Jun 07, 2024
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST,...
K240672 · EIH
Zhejiang Zahndent Biotechnology Co.,...
Dental · 88d
Cleared Jun 07, 2024
IPD Dental Implant Abutments
K240570 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 99d
Cleared Jun 06, 2024
Conical Platform Dental Implants System
K240202 · DZE
Noris Medical , Ltd.
Dental · 133d
Cleared Jun 05, 2024
Ti-Base & Master Fix
K240603 · NHA
Arum Dentistry Co., Ltd.
Dental · 93d
Cleared Jun 05, 2024
Tapered Pro Conical Implant System
K240187 · DZE
BioHorizons Implant Systems, Inc.
Dental · 133d
Cleared Jun 04, 2024
Slow Wave DS8 (SWDS802)
K240463 · MQC
Slow Wave, Inc.
Dental · 109d
Cleared Jun 03, 2024
LOCATOR Angled Abutment (Various)
K233587 · NHA
Zest Anchors, LLC
Dental · 208d
Cleared May 31, 2024
Fixtemp® C&B 4:1
K241226 · EBG
Dreve Denatmid GmbH
Dental · 29d
Cleared May 31, 2024
Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)
K240912 · EIH
Anhui Miisen Intelligence Technology...
Dental · 58d
Cleared May 31, 2024
S.I.N. Dental Implant System
K232821 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 261d
Cleared May 31, 2024
Mimics Enlight CMF
K223427 · LLZ
Materialise NV
Dental · 564d
Cleared May 29, 2024
EK Digital Abutments
K233389 · NHA
Hiossen, Inc.
Dental · 240d
Cleared May 28, 2024
Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR...
K240304 · KIF
Enpuno Biotechnology Co., Ltd.
Dental · 116d
Cleared May 24, 2024
Anti Grinding Guard
K240810 · OBR
Xiamen Yizhou Imp. & Exp. Co., Ltd.
Dental · 60d
Cleared May 24, 2024
KATANA Zirconia ONE For IMPLANT
K233285 · NHA
Kuraray Noritake Dental, Inc.
Dental · 238d
Cleared May 24, 2024
8plant Implant System
K231426 · DZE
Hoowon Edi Co., Ltd.
Dental · 373d
Cleared May 23, 2024
dima Print Teeth & Temp
K233868 · EBG
Kulzer, LLC
Dental · 169d
Cleared May 22, 2024
Paltop Short Implants
K232740 · DZE
Paltop Advanced Dental Solutions, Ltd.
Dental · 258d