Medical Device Manufacturer · US , York , PA

Dentsply Intl., Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2005

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dentsply Intl., Inc. Dental ✕

10 devices

1-10 of 10

Cleared Aug 20, 2014

ANKYLOS C/X IMPLANT SYSTEM

Cleared Jul 23, 2013

CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM

Cleared Feb 14, 2011

QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION

Cleared Oct 30, 2009

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II

Cleared May 22, 2009

ANKYLOS C/X DENTAL IMPLANT SYSTEM

Cleared Oct 29, 2008

DURASHIELD PLUS

Cleared Jan 28, 2008

Cleared Dec 19, 2007

DENTIN DESENSITIZER AGENT

Cleared Nov 27, 2006

MOUTHGUARD AND ALIGNER MATERIALS

Cleared Dec 08, 2005

BIOPURE MTAD ROOT CANAL CLEANSER