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
265–288 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Oct 10, 2025
HexaPLUS S OneDrill Implant System
K243078 · DZE
Osseofuse International, Inc.
Dental · 375d
Cleared Oct 09, 2025
Invisalign Specifix Attachment System
K252870 · NXC
Align Technology, Inc.
Dental · 30d
Cleared Oct 03, 2025
Anti Snore Mouthpiece
K250028 · LRK
Dongguan Yiyao Science & Technology...
Dental · 270d
Cleared Oct 02, 2025
G-Bond Universal
K251124 · KLE
GC America, Inc.
Dental · 174d
Cleared Sep 29, 2025
G-BLOCK
K253236 · EBF
Graphenano Dental S.L.
Dental
Cleared Sep 29, 2025
Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)
K250123 · DZL
Hager& Meisinger GmbH
Dental · 255d
Cleared Sep 29, 2025
Paltop Dental Implant System
K243983 · DZE
Paltop Advanced Dental Solutions, Ltd.
Dental · 280d
Cleared Sep 26, 2025
S.I.N. Dental Implant System
K251262 · DZE
S.I.N. Implant System Ltda
Dental · 156d
Cleared Sep 25, 2025
Root canal repair materials (nRoot BP)
K251465 · KIF
Enpuno Biotechnology Co., Ltd.
Dental · 135d
Cleared Sep 25, 2025
JDEvolution Plus L and JDEvolution Plus LE
K251148 · DZE
Jdentalcare Srl
Dental · 164d
Cleared Sep 24, 2025
Retraxil
K243910 · MVL
Kulzer, LLC
Dental · 279d
Cleared Sep 23, 2025
Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)
K253053 · EBF
Hangzhou SHINING3D Dental Technology...
Dental · 1d
Cleared Sep 19, 2025
Well-Root PT
K252285 · KIF
Vericom Co., Ltd.
Dental · 58d
Cleared Sep 19, 2025
VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10)
K251689 · ELC
Nakanishi, Inc.
Dental · 109d
Cleared Sep 19, 2025
EQUIA LC ONE
K250953 · EMA
GC America, Inc.
Dental · 175d
Cleared Sep 18, 2025
InnerView System
K251597 · EKX
Perimetrics, Inc.
Dental · 114d
Cleared Sep 17, 2025
DENTURE SOFT EX (Pink set)
K252035 · EBI
Kamemizu Chemical Industry Co., Ltd.
Dental · 79d
Cleared Sep 17, 2025
FG Bone Graft M
K244006 · LYC
Full Golden Biotech Co., Ltd.
Dental · 265d
Cleared Sep 17, 2025
Double Tube Herbst Appliance
K243752 · LRK
The Tmj Clinic PC
Dental · 286d
Cleared Sep 16, 2025
SFIT Abutment
K242287 · NHA
Cowellmedi Co., Ltd.
Dental · 410d
Cleared Sep 15, 2025
Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
K251869 · EGS
Premium Plus (Dongguan) Limited
Dental · 89d
Cleared Sep 11, 2025
Nylon flexTAP(R)
K252374 · LRK
Airway Technologies D/B/A Airway...
Dental · 43d
Cleared Sep 11, 2025
Serafin®
K251758 · NXC
Tns Co., Ltd.
Dental · 94d
Cleared Sep 04, 2025
Oniris
K250353 · LRK
Oniris
Dental · 209d