Medical Device Manufacturer · US , York , PA

Dentsply Interntional - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 2007

Recent clearances: X-SMART EASY, ELATION MB METAL REINFORCED PLASTIC BRACKET, ALLURE MB CERAMIC BRACKETS

View 13 510(k) Devices ↓

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dentsply Interntional Dental ✕

13 devices

1-12 of 13

Cleared Dec 02, 2009

Cleared Jul 24, 2009

ELATION MB METAL REINFORCED PLASTIC BRACKET

Cleared Mar 20, 2009

ALLURE MB CERAMIC BRACKETS

Cleared Jan 29, 2009

STER-MATE STERILE LAVAGE KIT

Cleared Nov 07, 2008

MYSTIQUE MB CERAMIC BRACKETS

Cleared May 22, 2008

PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION

Cleared Apr 18, 2008

MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM

Cleared Apr 11, 2008

COMPOSITE ALIGNER BUTTON

Cleared Mar 26, 2008

MTA ROOT CANAL SEALER

Cleared Jan 23, 2008

SELF-ADHESIVE RESIN CEMENT

Cleared Jan 07, 2008

MTA ADVANCED MATERIAL

Cleared Sep 04, 2007

OSTEOGRAF/N-300