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
49–72 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared May 19, 2026
SOGA Lasers therapy system family of Aurora handpiece (Aurora-S)
K253309 · NVK
Shenzhen Soga Technology Co., Ltd.
Dental · 232d
Cleared May 18, 2026
G-CEM UNIVERSAL
K254109 · EMA
GC America, Inc.
Dental · 150d
Cleared May 14, 2026
Dormiva Anti-Snoring Mouth Guard
K261134 · LRK
Koncept Innovators, Inc.
Dental · 37d
Cleared May 14, 2026
Any-Etch
K260485 · KLE
Mediclus Co., Ltd.
Dental · 90d
Cleared May 14, 2026
Bonalive Maxillofacial
K253883 · LYC
Bonalive , Ltd.
Dental · 161d
Cleared May 14, 2026
ET Healing Abutments
K253372 · NHA
Hiossen, Inc.
Dental · 226d
Cleared May 12, 2026
Promimic ZrP Surface Dental Implant
K252731 · DZE
Promimic AB
Dental · 257d
Cleared May 11, 2026
Dual Core
K260805 · EBF
Vericom Co., Ltd.
Dental · 60d
Cleared May 08, 2026
Smylio Aligners
K260788 · NXC
Smylio, Inc.
Dental · 59d
Cleared May 08, 2026
LingOral Dental Design System
K260419 · PNN
Hangzhou ChohoTech Co., Ltd.
Dental · 88d
Cleared May 07, 2026
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
K260460 · NHA
Institut Straumann AG
Dental · 85d
Cleared May 06, 2026
Denture Base
K260376 · EBI
Shandong Huge Dental Material...
Dental · 90d
Cleared May 01, 2026
Any-Com Seal
K260819 · EBC
Mediclus Co., Ltd.
Dental · 49d
Cleared May 01, 2026
VOCO Profluorid Varnish + BioMin
K252073 · LBH
Voco GmbH
Dental · 303d
Cleared Apr 30, 2026
UltraEZ
K261404 · LBH
Ultradent Products, Inc.
Dental · 1d
Cleared Apr 28, 2026
Surgical Microscope (OMS2360, OMS2380)
K252464 · NBL
Zumax Medical Co., Ltd.
Dental · 265d
Cleared Apr 27, 2026
Grandio disc multicolor
K261357 · EBF
Voco GmbH
Dental · 3d
Cleared Apr 27, 2026
Dura-Crown
K261356 · EBF
Hangzhou SHINING3D Dental Technology...
Dental · 3d
Cleared Apr 23, 2026
Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)
K260152 · EBF
Mmtech Projetos Tecnologicos...
Dental · 93d
Cleared Apr 17, 2026
Dura-Arch
K261261 · EBG
Hangzhou SHINING3D Dental Technology...
Dental · 1d
Cleared Apr 16, 2026
DESS Dental Smart Solutions
K253804 · NHA
Terrats Medical SL
Dental · 139d
Cleared Apr 15, 2026
SureSmile Aligner (ASSY500020)
K260722 · NXC
Dentsply Sirona, Inc.
Dental · 41d
Cleared Apr 15, 2026
Midas Restore
K260661
Sprintray, Inc.
Dental · 44d
Cleared Apr 15, 2026
REGEN Bioactive Cement
K253337 · EMA
Inter-Med, Inc.
Dental · 197d