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
1009–1032 of 12,595
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Aug 09, 2022
IMICRYL Composite, Composite Flow Materials
K220077 · EBF
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 211d
Cleared Aug 09, 2022
NOVA RESIN dual cure, self adhesive resin cement
K213609 · EMA
Imicryl Dis Malzemeleri Sanayi VE...
Dental · 267d
Cleared Aug 08, 2022
Dental Impression Material
K221668 · ELW
Chemoment Materials Co.,Ltd
Dental · 61d
Cleared Aug 03, 2022
Root ZX3
K213477 · EKZ
J. Morita USA, Inc.
Dental · 278d
Cleared Aug 02, 2022
BruxZir NOW
K220816 · EIH
Prismatik Dentalcraft, Inc.
Dental · 134d
Cleared Jul 29, 2022
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K221242 · EIH
Hunan Vsmile Biotechnology Co., Ltd.
Dental · 88d
Cleared Jul 29, 2022
Dental Handpiece, Model CA160, CA160L, and CA500L
K220577 · EGS
Micro-Nx Co., Ltd.
Dental · 151d
Cleared Jul 29, 2022
NobelProcera Zirconia N1 Base
K220048 · NHA
Nobel Biocare Services AG
Dental · 204d
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