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
1033–1056 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Jul 21, 2022
BTI Interna Narrow/Plus Dental Implant System UnicCa
K211952 · DZE
B.T.I. Biotechnology Institute, Sl.
Dental · 393d
Cleared Jul 20, 2022
Root Apex Locator
K212178 · LQY
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 373d
Cleared Jul 18, 2022
OSSIX Breeze
K212509 · NPL
Datum Dental, Ltd.
Dental · 343d
Cleared Jul 18, 2022
KLS Martin Individual Patient Solutions
K210731 · JEY
KLS-Martin L.P.
Dental · 494d
Cleared Jul 15, 2022
OK Handpiece
K221814 · EFB
Jaintek Co.,Ltd
Dental · 23d
Cleared Jul 15, 2022
Kontact Dental Implant System
K213997 · DZE
Biotech Dental, Sas
Dental · 206d
Cleared Jul 15, 2022
Tatum Surgical Dental Implant System
K213576 · DZE
Suncoast Dental, Inc. Dba Tatum Surgical
Dental · 247d
Cleared Jul 14, 2022
KDF Zirconia Disc
K221429 · EIH
Denken-Highdental Co., Ltd.
Dental · 59d
Cleared Jul 14, 2022
SmileSeries
K221097 · NXC
Ordont Orthodontic Laboratories, Inc.
Dental · 91d
Cleared Jul 14, 2022
TruAbutment DS, TruBase
K213961 · NHA
Truabutment, Inc.
Dental · 206d
Cleared Jul 13, 2022
SNUCONE Bone Level Implant System
K210354 · DZE
Snucone Co., Ltd.
Dental · 520d
Cleared Jul 08, 2022
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K221051 · EIH
Changsha Honchon Technology Co., Ltd.
Dental · 88d
Cleared Jul 08, 2022
Adin Short Implants
K212775 · DZE
Adin Dental Implants Systems , Ltd.
Dental · 310d
Cleared Jul 08, 2022
KLS Martin IPS Preprosthetic
K210228 · ELE
KLS-Martin L.P.
Dental · 526d
Cleared Jul 07, 2022
Stratasys TrueDent
K220771 · EBI
Stratasys, Ltd.
Dental · 113d
Cleared Jul 06, 2022
UniPrime A, UniPrime E, UniPrime E/C
K221033 · KLE
S&C Polymer Silicon- Und Composite...
Dental · 90d
Cleared Jul 05, 2022
Osteon Precision Milled Suprastructure
K221019 · NHA
Implant Solutions Pty Ltd (Aka Osteon...
Dental · 90d
Cleared Jul 05, 2022
CediTEC
K220743 · EBI
Voco GmbH
Dental · 113d
Cleared Jul 01, 2022
J-Temp
K221909 · EBF
Ultradent Products, Inc.
Dental · 1d
Cleared Jul 01, 2022
Dental diode laser, SOGA Laser, ILaser II
K211150 · NVK
Shenzhen Soga Technology Co., Ltd.
Dental · 438d
Cleared Jun 30, 2022
Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue...
K212785 · DZE
Blue Sky Bio, LLC
Dental · 302d
Cleared Jun 29, 2022
BruxZir Opaque Coloring Liquid
K220960 · EIH
Prismatik Dentalcraft, Inc.
Dental · 89d
Cleared Jun 29, 2022
Coloring Liquid
K220017 · EIH
Dongguan Xiangtong Co., Ltd.
Dental · 175d
Cleared Jun 27, 2022
Navident
K210947 · PLV
Claronav, Inc.
Dental · 454d