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
1801–1824 of 12,659
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