Medical Device Manufacturer · US , Walker , MI

Dentsply Intl.

279 submissions · 279 cleared · Since 1976
279
Total
279
Cleared
0
Denied

Dentsply Intl. — FDA 510(k) Submissions

Dentsply Intl. has submitted 279 FDA 510(k) premarket notifications since 1976, of which 279 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Material, Tooth Shade, Resin, Powder, Porcelain, Agent, Tooth Bonding, Resin, Cement, Dental, Material, Impression . Use the specialty filter in the sidebar to narrow results.

279 devices
1–25 of 279
IRIS - HIGH STRENGTH GLASS CERAMIC
K123615 · EIH Powder, Porcelain · Dental
Feb 2013 91d
FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS
K072730 · NHA Abutment, Implant,... · Dental
Mar 2008 183d
XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE
K070538 · KLE Agent, Tooth Bonding, Resin · Dental
Mar 2007 16d
CARRARA VOLUMIA
K070019 · EIH Powder, Porcelain · Dental
Jan 2007 23d
PRE-IMPRESSION CONDITIONING SOLUTION
K061427 · ELW Material, Impression · Dental
Jun 2006 34d
CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131
K052334 · ELC Scaler, Ultrasonic · Dental
Sep 2005 7d
ECLIPSE BONDING AGENT
K051707 · KLE Agent, Tooth Bonding, Resin · Dental
Jul 2005 18d
XENO ADHESIVE WITH ACTIVATOR
K051463 · KLE Agent, Tooth Bonding, Resin · Dental
Jul 2005 39d
MODIFICATION TO: CERCON BASE
K051462 · EIH Powder, Porcelain · Dental
Jun 2005 21d
DYRACT EXTRA RESTORATIVE
K050880 · EBF Material, Tooth Shade, Resin · Dental
Apr 2005 16d
LC BRACKET ADHESIVE SYSTEM
K050750 · DYH Adhesive, Bracket And... · Dental
Apr 2005 14d
DUCERA ALLCERAM
K043247 · EIH Powder, Porcelain · Dental
Dec 2004 29d
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
K042905 · NJM Bracket, Ceramic,... · Dental
Nov 2004 14d
DYRACT CEM PLUS CEMENT
K041272 · EMA Cement, Dental · Dental
Oct 2004 159d
ORTHODONTIC CERAMIC BRACKETS
K042178 · NJM Bracket, Ceramic,... · Dental
Aug 2004 19d
CERCON CERAM EXPRESS CERAMIC SYSTEM
K041707 · EIH Powder, Porcelain · Dental
Jul 2004 37d
CALIBRA CEMENT
K040906 · EMA Cement, Dental · Dental
Jun 2004 70d
DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125
K041141 · EFB Handpiece, Air-powered,... · Dental
Jun 2004 47d
INTEGRITY TEMPORARY CEMENT
K040895 · EMA Cement, Dental · Dental
May 2004 45d
IDEAL 1 ORTHODONTIC BAND CEMENT
K040375 · DYH Adhesive, Bracket And... · Dental
Apr 2004 45d
CARRARA INTERACTION CERAMIC SYSTEM
K040635 · EIH Powder, Porcelain · Dental
Mar 2004 20d
DUCERAM PLUS CERAMIC SYSTEM
K040420 · EIH Powder, Porcelain · Dental
Mar 2004 29d
DUCERAGOLD PORCELAINS
K040421 · EIH Powder, Porcelain · Dental
Mar 2004 29d
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
K033703 · DYH Adhesive, Bracket And... · Dental
Feb 2004 73d
CARRARA PRESS SYSTEM
K033667 · EIH Powder, Porcelain · Dental
Jan 2004 63d

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