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
745–768 of 12,659
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Nov 21, 2023
NemoCast
K232549 · PNN
Software Nemotec S.L.
Dental · 90d
Cleared Nov 21, 2023
Meta G UCLA Abutment
K232546 · NHA
Cowellmedi Co., Ltd.
Dental · 90d
Cleared Nov 21, 2023
Ultrasonic Scaler Tips
K230641 · ELC
Guilin Refine Medical Instrument Co.,...
Dental · 258d
Cleared Nov 17, 2023
Multi-Unit DAS System
K231559 · NHA
Talladium Espa?a, SL
Dental · 171d
Cleared Nov 15, 2023
Curing Light, Model: MaxCure 9
K223414 · EBZ
Guilin Refine Medical Instrument Co.,...
Dental · 370d
Cleared Nov 14, 2023
Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)
K233434 · LRK
Prismatik Dentalcraft, Inc.
Dental · 32d
Cleared Nov 14, 2023
saremco print BRIDGETEC
K232050 · EBF
Saremco Dental AG
Dental · 127d
Cleared Nov 14, 2023
Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow,...
K231097 · NHA
Prismatik Dentalcraft, Inc.
Dental · 210d
Cleared Nov 09, 2023
VarseoSmile TriniQ
K233596 · EBF
Bego Bremer Goldschl?gerei Wilh....
Dental · 1d
Cleared Nov 09, 2023
Dental Handpiece, Wireless Endodontic Handpiece, endoit
K232810 · EKX
Micro-Nx Co., Ltd.
Dental · 58d
Cleared Nov 06, 2023
Mouth Guard (ATG0603R)
K231865 · OBR
Reazeal Corp
Dental · 133d
Cleared Nov 02, 2023
BASE290 LED Curing Light
K233518 · EBZ
Handpiece Headquarters
Dental · 1d
Cleared Nov 02, 2023
Fibercure
K232076 · QNF
Lumendo AG
Dental · 112d
Cleared Nov 01, 2023
TERA HARZ II
K233502 · EBF
Graphy, Inc.
Dental · 1d
Cleared Oct 31, 2023
Neodent Implant System - GM Zygomatic Implant System
K232099 · DZE
JJGC Ind?stria e Com?rcio de...
Dental · 110d
Cleared Oct 30, 2023
AOT & T-L Abutment
K231874 · NHA
Truabutment, Inc.
Dental · 126d
Cleared Oct 27, 2023
BluTube® Dental Unit Water Purification Cartridge (BluTube®)
K232393 · QYJ
Proedge Dental Products, Inc.
Dental · 79d
Cleared Oct 27, 2023
Centrix FluoroSilver Silver Diamine Fluoride 38%
K222459 · PHR
Centrix, Inc.
Dental · 438d
Cleared Oct 26, 2023
SIMDA abutment
K232271 · NHA
Simda Co., Ltd.
Dental · 87d
Cleared Oct 25, 2023
UNIdental Symphony Implant System
K221315 · DZE
Unidental Co., Ltd.
Dental · 537d
Cleared Oct 20, 2023
Lucitone Digital Print Denture System
K231578 · EBI
Dentsply Sirona
Dental · 142d
Cleared Oct 20, 2023
NextDent Base
K231388 · EBI
Vertex-Dental B.V.
Dental · 161d
Cleared Oct 18, 2023
INNO SLA Submerged Narrow Implant System
K231395 · DZE
Cowellmedi Co., Ltd.
Dental · 156d
Cleared Oct 18, 2023
Byte Aligner System
K230199 · NXC
Dentsply Sirona, Inc.
Dental · 266d