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
937–960 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Nov 04, 2022
Yomi Robotic System
K222049 · QRY
Neocis, Inc.
Dental · 115d
Cleared Nov 03, 2022
Tera Harz Clear
K223355 · NXC
Graphy, Inc.
Dental · 1d
Cleared Oct 28, 2022
Stela Capsule System
K222583 · EBF
Sdi Limited
Dental · 63d
Cleared Oct 28, 2022
Stela Automix System
K222581 · EBF
Sdi Limited
Dental · 63d
Cleared Oct 27, 2022
DESS Dental Smart Solutions
K222288 · NHA
Terrats Medical SL
Dental · 90d
Cleared Oct 27, 2022
S.I.N. Dental Implant System
K222231 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 94d
Cleared Oct 27, 2022
CUSTMBITE Snoring System
K221322 · LRK
Dental Choice Holdings, LLC
Dental · 174d
Cleared Oct 26, 2022
DESS Dental Smart Solutions
K222269 · NHA
Terrats Medical SL
Dental · 90d
Cleared Oct 26, 2022
Preat Abutments
K220823 · NHA
Preat Corporation
Dental · 219d
Cleared Oct 24, 2022
Soft Palate Elevator
K222127 · LRK
The Tmj Clinic PC
Dental · 98d
Cleared Oct 21, 2022
IPD Dental Implant Abutments
K222215 · NHA
Implant Protesis Dental 2004, S.L.
Dental · 88d
Cleared Oct 21, 2022
NextDent Ortho Flex
K221022 · MQC
Vertex-Dental B.V.
Dental · 198d
Cleared Oct 20, 2022
BTI Interna Dental Implant System UnicCa - Prosthetic Components
K213106 · NHA
B.T.I. Biotechnology Institute, Sl.
Dental · 391d
Cleared Oct 19, 2022
Infinity Pro, Logic, Quality, Sprint
K213742 · EIA
Olsen Ind?stria E Com?rcio S.A.
Dental · 324d
Cleared Oct 19, 2022
Proximerge 2 Dental Implant System
K211409 · DZE
Quadric Biomed, LLC
Dental · 531d
Cleared Oct 14, 2022
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied...
K214054 · DYH
Tp Orthodontics, Inc.
Dental · 291d
Not Cleared Oct 14, 2022
The Cooral System
DEN210027 · QUA
Braincool AB
Dental · 469d
Cleared Oct 13, 2022
IM/ST Fixture System
K212702 · DZE
Guilin Fiteeth Medical Instrument...
Dental · 413d
Cleared Oct 13, 2022
CREOKORREKT Aligners
K211427 · NXC
Creodent Prosthetics, Ltd.
Dental · 524d
Cleared Oct 12, 2022
TrusFIL-Flow Flowable Composite Restorative
K221510 · EBF
Rizhao Huge Biomaterials Company, Ltd.
Dental · 141d
Cleared Oct 12, 2022
PiezoImplant System
K211872 · NRQ
Rex Implants, Inc.
Dental · 482d
Cleared Oct 11, 2022
Renamel® Microhybrid
K222435 · EBF
Cosmedent, Inc.
Dental · 60d
Cleared Oct 07, 2022
Protect-It Custom Fit Dental Guard
K222424 · OBR
Doc Brands, Inc.
Dental · 57d
Cleared Oct 07, 2022
Nuvola
K222418 · NXC
Gruppo Europeo Ortodonzia Srl
Dental · 58d