Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Dental ×
12,659 results
721–744 of 12,659
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