Medical Device Manufacturer · IL , Ra'Ananna

Opusdent , Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2000

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Opusdent , Ltd. General & Plastic Surgery ✕

5 devices

1-5 of 5

Cleared Aug 07, 2002

OPUSDUO EC DENTAL LASER SYSTEM

General & Plastic Surgery · 90d

Cleared Jan 08, 2002

OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND

General & Plastic Surgery · 26d

Cleared Aug 30, 2001

OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND

General & Plastic Surgery · 84d

Cleared Dec 12, 2000

OPUS 20, MODEL 1ST

General & Plastic Surgery · 85d

Cleared Jun 23, 2000

OPUS 10 DENTAL DIODE LASER

General & Plastic Surgery · 87d