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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Dental ×
12,558 results
10993–11016 of 12,558
Search insights Median review: 86d Cleared: 100% Top manufacturer: Dentsply Intl. Lead specialty: Dental
Cleared May 19, 1986
SUPERLON (UNILON) CARBOXYLATE CEMENT
K861685 · EMA
Carlisle Laboratories, Inc.
Dental · 17d
Cleared May 12, 1986
MONARCH II BLEACHING INSTRUMENT
K854692 · EEG
Almore Intl., Inc.
Dental · 172d
Cleared May 12, 1986
DENCLENZ
K854995 · EFT
Creighton Products Corp.
Dental · 151d
Cleared May 12, 1986
CENTRIX PCR MOLAR MATRIX FORMS (BANDS)
K861581 · DZN
Centrix, Inc.
Dental · 13d
Cleared May 02, 1986
ORTHOJOIN, ORTHODONTIC ADHESIVE
K861118 · DYH
Ortho Source
Dental · 38d
Cleared Apr 30, 1986
OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH
K861083 · LYC
Coors Biomedical Co.
Dental · 40d
Cleared Apr 30, 1986
OSTEOGRAF/AR ALVEOLAR RID HYDROX, 18-40 MESH
K861084 · LYC
Coors Biomedical Co.
Dental · 40d
Cleared Apr 30, 1986
BISCO'S PORCELAIN VENEER SYSTEM
K861148 · EBF
Bisco, Inc.
Dental · 35d
Cleared Apr 25, 1986
DB PRECISION IMPLANT SYSTEM, 2000 SERIES
K860982 · DZE
Driskell Bioengineering
Dental · 39d
Cleared Apr 25, 1986
GLASIONOMER BASE CEMENT
K861005 · EMA
Shofu Dental Corp.
Dental · 38d
Cleared Apr 23, 1986
NO FLOSS FLOSSER
K854326 · JEQ
Rgm Assoc.
Dental · 177d
Cleared Apr 21, 1986
SUPER ALGIN, ALGINAMINE, EMPRESS DUSTFREE
K853089 · ELW
Psp Dental Co., Ltd.
Dental · 272d
Cleared Apr 17, 1986
SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220
K860118 · EFT
Northern Electric Co. Div. of Sunbeam...
Dental · 94d
Cleared Apr 17, 1986
PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT
K860653 · DZE
Otc/America
Dental · 55d
Cleared Apr 17, 1986
PHOTO CLEARFIL OPAQUER
K860708 · EBF
Kuraray Co.
Dental · 50d
Cleared Apr 17, 1986
ACRYLIC SOLDER
K861239 · EBI
Parker Laboratories, Inc.
Dental · 15d
Cleared Apr 17, 1986
PERMABAND (ORTHODONTIC ADHESIVE)
K861258 · DYH
Ortho Source
Dental · 14d
Cleared Apr 11, 1986
FLUOROSEAL, DENTIN SEALER AND CAVITY LINER
K860633 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 50d
Cleared Apr 11, 1986
EXEL DENTAL NEEDLE
K861150 · DZM
Exel Intl.
Dental · 16d
Cleared Apr 11, 1986
ORTHOSOURCE ETCH SYSTEMS
K861245 · EBC
Ortho Source
Dental · 9d
Cleared Apr 08, 1986
NUCOR COMPOSITE RESTORATIVE MATERIAL PASTE/LIQUID
K860626 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 48d
Cleared Apr 04, 1986
EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA
K853094 · EBI
Psp Dental Co., Ltd.
Dental · 255d
Cleared Apr 04, 1986
KYOCERA BIOCERAM POROUS DENTAL IMPLANT
K860360 · DZE
Kyocera International, Inc.
Dental · 64d
Cleared Apr 03, 1986
PSP C & B TEMP
K853092 · EBG
Psp Dental Co., Ltd.
Dental · 254d