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
1753–1776 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Aug 23, 2019
CustMBite Dental Guard
K183315 · OBR
Dental Choice Holdings, LLC
Dental · 266d
Cleared Aug 22, 2019
Osstell Beacon
K181888 · EKX
Osstell AB
Dental · 405d
Cleared Aug 16, 2019
Piezon Built-in Kit, Piezon Built-in Kit LED
K191079 · ELC
E.M.S Electro Medical Systems S.A
Dental · 115d
Cleared Aug 14, 2019
IS-III active System_S-narrow Type
K190849 · DZE
Neobiotech Co., Ltd.
Dental · 135d
Cleared Aug 12, 2019
Blue Sky Bio Zygomatic Implant System
K190491 · NHA
Blue Sky Bio, LLC
Dental · 165d
Cleared Aug 09, 2019
Bone Screw, Bone Tack
K182881 · DZL
Osstem Implant Co., Ltd.
Dental · 298d
Cleared Aug 05, 2019
Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech...
K191222 · NHA
Prismatik Dentalcraft, Inc.
Dental · 90d
Cleared Aug 05, 2019
LunaGuard Nighttime Dental Protector
K191033 · OBR
Mckeon Products
Dental · 109d
Cleared Jul 29, 2019
Shaders ZR
K190569 · EIH
Digital Age Dental Lab
Dental · 145d
Cleared Jul 29, 2019
Helioseal F Plus
K190339 · EBC
Ivoclar Vivadent, AG
Dental · 165d
Cleared Jul 25, 2019
Maxima Electric System
K180845 · EBW
Handpiece Headquarters - Hpr, Inc.
Dental · 479d
Cleared Jul 18, 2019
Qraypen
K183121 · EIA
AIOBIO Co., Ltd.
Dental · 251d
Cleared Jul 18, 2019
Ziacom Dental Implant Systems
K182908 · DZE
Ziacom Medical, S.L.
Dental · 274d
Cleared Jul 17, 2019
Silent Nite sl
K183270 · LRK
Prismatik Dentalcraft, Inc.
Dental · 236d
Cleared Jul 17, 2019
The POD
K182820 · MQC
Advanced Facialdontics, LLC
Dental · 286d
Cleared Jul 15, 2019
A.B. DENTAL DEVICES Dental Implants System
K182455 · NHA
A.B. Dental Device , Ltd.
Dental · 311d
Cleared Jul 12, 2019
Novidia Bulk Fill Flow Composite
K182714 · EBF
Nobio , Ltd.
Dental · 288d
Cleared Jul 12, 2019
Osstem Abutment System
K182091 · NHA
Osstem Implant Co., Ltd.
Dental · 343d
Cleared Jul 11, 2019
Zygomatic Implants
K190718 · DZE
Jjgc Industria E Comercio DE...
Dental · 113d
Cleared Jul 11, 2019
GC FujiCEM 2 (Improved)
K182854 · EMA
GC America, Inc.
Dental · 274d
Cleared Jul 10, 2019
VeriSplint
K190107 · MQC
Whip Mix Corporation
Dental · 169d
Cleared Jul 10, 2019
Conometric Abutments
K183079 · NHA
Dentsply Sirona, Inc.
Dental · 247d
Cleared Jul 08, 2019
Surgikor Dental Implant System
K182615 · DZE
Surgikor, LLC
Dental · 290d
Cleared Jul 08, 2019
PRAMA White Implant Systems
K180365 · DZE
Sweden & Martina S.P.A.
Dental · 511d