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
649–672 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jan 05, 2024
Fusion Core DC Flo
K231263 · EBF
Prevest Denpro Limited
Dental · 248d
Cleared Jan 04, 2024
Anthogyr FlexiBase® titanium bases for Axiom® BL
K231072 · NHA
Anthogyr
Dental · 265d
Cleared Dec 29, 2023
URIS Smart Path Implant System & Prosthetic
K230438 · DZE
Truabutment, Inc.
Dental · 311d
Cleared Dec 29, 2023
UniFit Dental Implant System
K223714 · DZE
Adin Dental Implant Systems , Ltd.
Dental · 382d
Cleared Dec 22, 2023
3M™ Transbond™ Orthodontic Adhesive
K234043 · DYH
3M Unitek Orthodontic Products
Dental · 1d
Cleared Dec 22, 2023
TopCEM Dual Cure Resin Cement
K233082 · EBF
Rizhao Huge Biomaterials Company, Ltd.
Dental · 87d
Cleared Dec 22, 2023
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
K232717 · LQY
Changzhou Haili Medical Co., Ltd.
Dental · 108d
Cleared Dec 21, 2023
Dental Glass Ceramics
K233016 · EIH
Shenzhen Yurucheng Dental Materials...
Dental · 90d
Cleared Dec 21, 2023
Elos Accurate Customized Abutment
K231307 · NHA
Elos Medtech Pinol A/S
Dental · 230d
Cleared Dec 20, 2023
INNO SLA Submerged Hybrid Ti-Base System
K231411 · NHA
Cowellmedi Co., Ltd.
Dental · 218d
Cleared Dec 19, 2023
ZENEX Implant System_Short
K233163 · DZE
Izenimplant Co., Ltd.
Dental · 83d
Cleared Dec 19, 2023
Angled Abutment
K232560 · NHA
Arum Dentistry Co., Ltd.
Dental · 118d
Cleared Dec 18, 2023
S-Plant Dental Implant System
K231429 · DZE
Idis Co., Ltd.
Dental · 215d
Cleared Dec 15, 2023
Invisalign Palatal Expander System
K232887 · NXC
Align Technology, Inc.
Dental · 88d
Cleared Dec 14, 2023
C50
K223470 · NBL
Sopro
Dental · 392d
Cleared Dec 13, 2023
SaliPen
K232063 · QTT
Saliwell , Ltd.
Dental · 155d
Cleared Dec 13, 2023
Neodent Implant System - Zirconia Implant System
K231803 · NHA
JJGC Ind?stria e Com?rcio de...
Dental · 176d
Cleared Dec 13, 2023
CLEARFIL Universal Bond Quick 2
K231039 · KLE
Kuraray Noritake Dental, Inc.
Dental · 245d
Cleared Dec 11, 2023
EDS Calculus Softener TURBO CR
K223340 · ELC
Essential Dental Systems, Inc.
Dental · 405d
Cleared Dec 08, 2023
BTI Interna Prosthetic Components
K232750 · NHA
B.T.I. Biotechnology Institute, Sl.
Dental · 91d
Cleared Dec 08, 2023
Lumina-PTFE Titanium
K221851 · NPK
Criteria Industria E Comercio DE...
Dental · 529d
Cleared Dec 07, 2023
ARi ExCon Implant System
K231967 · DZE
Megagen Implant Co., Ltd.
Dental · 157d
Cleared Dec 07, 2023
S.I.N. Dental Implant System
K231127 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 231d
Cleared Dec 05, 2023
SS Abutment System
K232220 · NHA
Osstem Implant Co., Ltd.
Dental · 132d