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
673–696 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
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
Cleared Dec 01, 2023
Dental Glass Ceramics Blocks
K232438 · EIH
Aibodent Biotechnology Co., Ltd.
Dental · 109d
Cleared Dec 01, 2023
Single Platform SP1 Implant System
K232418 · DZE
Southern Implants (Pty), Ltd.
Dental · 112d
Cleared Dec 01, 2023
AlignerFlow LC
K231817 · DYH
Voco GmbH
Dental · 163d
Cleared Nov 28, 2023
C.A.R.E. Appliance (DNA, mRNA, mmRNA)
K230947 · LRK
Vivos Therapeutics, Inc.
Dental · 238d
Cleared Nov 28, 2023
Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
K222845 · MQC
Frey Oral Technologies, LLC
Dental · 433d
Cleared Nov 27, 2023
PF Keep
K233171 · EBI
Clemde SA DE CV
Dental · 60d
Cleared Nov 27, 2023
Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo...
K232222 · NVK
Medency S.R.L.
Dental · 124d
Cleared Nov 22, 2023
HealiAid Dental Collagen Wound Dressing
K230529 · OLR
Maxigen Biotech, Inc.
Dental · 268d