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
3529–3552 of 12,611
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared Oct 03, 2011
SILVER CARE ANITBACTERIAL TOOTHBRUSH
K102871 · EFW
Piave Spazzolificio S.P.A.
Dental · 368d
Cleared Oct 03, 2011
PROSTHETIC SYSTEM
K110308 · NHA
Osstem Implant Co., Ltd.
Dental · 243d
Cleared Oct 03, 2011
PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM,...
K111169 · DZB
Kwang Myung Daicom, Inc.
Dental · 160d
Cleared Oct 03, 2011
STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
K111357 · DZE
Straumann USA
Dental · 140d
Cleared Sep 29, 2011
EQUIMATRIX
K111816 · NPM
Luitpold Pharmaceuticals, Inc.
Dental · 94d
Cleared Sep 29, 2011
PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID
K111832 · EBI
Heraeus Kulzer, LLC
Dental · 93d
Cleared Sep 26, 2011
ASTRA TECH IMPLANT SYSTEM
K111287 · DZE
Astra Tech AB
Dental · 143d
Cleared Sep 26, 2011
SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS
K111809 · OAT
Biomaterials Korea, Inc.
Dental · 91d
Cleared Sep 23, 2011
ULTRASEAL XT HYDRO
K112517 · EBC
Ultradent Products, Inc.
Dental · 23d
Cleared Sep 21, 2011
Z BOND, PRELUDE ONE
K111876 · KLE
Danville Materials, Inc.
Dental · 82d
Cleared Sep 16, 2011
BEAUTISEALANT
K111782 · EBC
Shofu Dental Corporation
Dental · 84d
Cleared Sep 16, 2011
PERMASHADE VENEER CEMENT
K111836 · EMA
Ultradent Products, Inc.
Dental · 79d
Cleared Sep 15, 2011
SEVEN IMPLANTS
K103089 · DZE
Mis - Implant Technologies , Ltd.
Dental · 331d
Cleared Sep 15, 2011
BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL
K111003 · DZE
Biodenta Swiss AG
Dental · 157d
Cleared Sep 14, 2011
KJ SUBMERGED SYSTEM
K103810 · DZE
Kj Meditech Co., Ltd.
Dental · 259d
Cleared Sep 14, 2011
THE INSYNC CERAMIC SYSTEM
K111743 · EIH
Jensen Industries, Inc.
Dental · 85d
Cleared Sep 14, 2011
PADLOCK
K111814 · DYH
Reliance Orthodontic Products, Inc.
Dental · 79d
Cleared Sep 13, 2011
COLGATE DESENSITIZING DENTAL CREAM
K103461 · LBH
Colgate-Palmolive Co.
Dental · 293d
Cleared Sep 12, 2011
JUELL HARD CURE
K111177 · EBI
Juell Dental
Dental · 138d
Cleared Sep 12, 2011
JUELL SOFT CURE
K111178 · EBI
Juell Dental
Dental · 138d
Cleared Sep 12, 2011
SFI-BAR (R) IMPLANT ADAPTER SPI (R) ELEMENT PF 0 4.0 / H 3.0 / H 4.0 / H 5.0...
K111390 · NHA
Cendres & Metaux SA
Dental · 117d
Cleared Sep 12, 2011
STRAUMANN TIBRUSH
K111724 · ELB
Straumann USA
Dental · 84d
Cleared Sep 08, 2011
PROLINK ADHESIVES (PROLINK, PROLINK SE)
K110403 · KLE
Silmet , Ltd.
Dental · 209d
Cleared Sep 07, 2011
EVADYNE TEMPORARY CROWN AND BRIDGE RESIN
K111666 · EBG
Neodental Chemical Products Co., Ltd.
Dental · 85d