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
961–984 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
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
Cleared Oct 07, 2022
Mico One Orthodontic Screw
K202163 · OAT
Ze Fang Technology Co., Ltd.
Dental · 795d
Cleared Oct 06, 2022
Perfit FS Dental Zirconia Fully Sintered Block
K222686 · EIH
Vatech Acucera, Inc.
Dental · 30d
Cleared Oct 06, 2022
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore...
K221889 · LRK
Prosomnus Sleep Technologies
Dental · 99d
Cleared Oct 05, 2022
ClearCorrect System
K220140 · NXC
Clearcorrect, LLC
Dental · 260d
Cleared Sep 30, 2022
EmbedMed
K220366 · DZJ
3D Lifeprints UK , Ltd.
Dental · 234d
Cleared Sep 30, 2022
Kerecis Oral
K213904 · NPL
Kerecis
Dental · 290d
Cleared Sep 28, 2022
Dental Air Polishing Handpiece
K221548 · EFB
Guilin Woodpecker Medical Instrument...
Dental · 124d
Cleared Sep 27, 2022
Dental Implantation Systems, Dental Electrical Motors
K220831 · EBW
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 189d