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
1393–1416 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Dec 04, 2020
Neocis Guidance System (NGS) with Yomi Plan v2.0
K202264 · PLV
Neocis, Inc.
Dental · 115d
Cleared Dec 04, 2020
TTBIO EVOCLEAN Ultrasonic Scaler
K201317 · ELC
Ttbio Corp.
Dental · 200d
Cleared Dec 03, 2020
NobelProcera Zirconia Implant Bridge
K202452 · NHA
Nobel Biocare AB
Dental · 98d
Cleared Dec 03, 2020
Magic UCLA Abutment System
K202418 · NHA
Innobiosurg Co., Ltd.
Dental · 101d
Cleared Dec 03, 2020
Braces on Demand Bracket
K201940 · DYW
Braces on Demand, Inc.
Dental · 143d
Cleared Dec 01, 2020
Z5-TL
K201712 · DZE
Z-Systems AG
Dental · 161d
Cleared Nov 30, 2020
Bright High Flow
K200155 · EBF
Genoss Co., Ltd.
Dental · 313d
Cleared Nov 27, 2020
E-Guard
K201173 · MQC
Envisiontec GmbH
Dental · 210d
Cleared Nov 25, 2020
Night Guard
K202465 · MQC
3D Diagnostix, Inc.
Dental · 90d
Cleared Nov 25, 2020
PRE-MILLED Abutment
K202269 · NHA
Mit Global Co., Ltd.
Dental · 106d
Cleared Nov 24, 2020
Monet Curing Laser
K201904 · QNF
CAO Group, Inc.
Dental · 138d
Cleared Nov 24, 2020
G-CEM ONE
K200798 · EMA
GC America, Inc.
Dental · 243d
Cleared Nov 23, 2020
Somnos Anti-Snoring Mouth Guard
K201484 · LRK
Koncept Innovators, LLC
Dental · 172d
Cleared Nov 20, 2020
ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device...
K202529 · LRK
Prosomnus Sleep Technologies, Inc.
Dental · 80d
Cleared Nov 20, 2020
LC ResinCal PC
K202413 · EJK
S&C Polymer Silicon- Und Composite...
Dental · 88d
Cleared Nov 19, 2020
FotoDent denture
K200580 · EBI
Dreve Dentamid GmbH
Dental · 259d
Cleared Nov 17, 2020
S.I.N. Dental Implant System
K200992 · DZE
S.I.N. ? Sistema DE Implante Nacional...
Dental · 216d
Cleared Nov 16, 2020
TiUltra Implants and Xeal Abutments
K202344 · DZE
Nobel Biocare AB
Dental · 90d
Cleared Nov 16, 2020
Freeprint denture
K200461 · EBI
Detax GmbH & Co. KG
Dental · 265d
Cleared Nov 16, 2020
Telio CAD Abutment Solutions- extra systems
K193193 · NHA
Ivoclar Vivadent, AG
Dental · 363d
Cleared Nov 13, 2020
Ceramir Restore QuikCap
K201937 · EMA
Doxa Dental AB
Dental · 123d
Cleared Nov 13, 2020
Kerecis Gingiva Graft
K192612 · NPL
Kerecis Limited
Dental · 420d
Cleared Nov 12, 2020
TP Orthodontics Clear Aligner System
K193385 · NXC
Tp Orthodontics, Inc.
Dental · 342d
Cleared Nov 10, 2020
JTK Dental Implant System
K183044 · DZE
Jiangyin Jintech Biotech Co., Ltd.
Dental · 739d