Medical Device Manufacturer · IL , Ra'Ananna

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

5 submissions · 5 cleared · Since 2000

Recent clearances: OPUSDUO EC DENTAL LASER SYSTEM, OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND, OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND

View 5 510(k) Devices ↓
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
K021508 · GEX
General & Plastic Surgery · 90d
Cleared Jan 08, 2002
OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
K014100 · GEX
General & Plastic Surgery · 26d
Cleared Aug 30, 2001
OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND
K011769 · GEX
General & Plastic Surgery · 84d
Cleared Dec 12, 2000
OPUS 20, MODEL 1ST
K002899 · GEX
General & Plastic Surgery · 85d
Cleared Jun 23, 2000
OPUS 10 DENTAL DIODE LASER
K000990 · GEX
General & Plastic Surgery · 87d
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