Medical Device Manufacturer · US , Walker , MI

Dentsply Intl. - FDA 510(k) Cleared Devices

279 submissions · 279 cleared · Since 1976

279

Total

279

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dentsply Intl. Radiology ✕

5 devices

1-5 of 5

Cleared Mar 14, 2000

ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200...

Radiology · 85d

Cleared Sep 07, 1999

GENDEX 765DC, MODEL 110-0154

Radiology · 34d

Cleared Apr 14, 1998

DENOPTIX BARRIER ENVELOPE (SIZE 0-4)

Radiology · 61d

Cleared Dec 23, 1996

ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM

Radiology · 33d

Cleared Mar 01, 1996

ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM

Radiology · 59d