FLEXLAB 3.6, ACCELERATOR A3600

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AIRPREP SYSTEM - MODEL 9001

FDA 510(k)

FDA Class 2 ·Dental

ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES

FDA 510(k)

FDA Class 2 ·Dental

ASI CYSTOLASE LASER CYSTOSCOPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ASI UROPLASTY LASER CYSTOSCOPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·CSI (CROFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS

TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT

FDA 510(k)

FDA Class 2 ·Dental

Polibond

FDA 510(k)

FDA Class 2 ·Dental

ICE Ceramics, ICE Stains, Fresco

FDA 510(k)

FDA Class 2 ·Dental

Prettau, ICE, Z-White zirconia blanks

FDA 510(k)

FDA Class 2 ·Dental

Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue

FDA 510(k)

FDA Class 2 ·Dental

Color Liquid, Vita Liquid

FDA 510(k)

FDA Class 2 ·Dental

ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray

FDA 510(k)

FDA Class 2 ·Radiology

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA

FDA 510(k)

FDA Class 2 ·Dental

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer

FDA 510(k)

FDA Class 2 ·Microbiology

CSL X-RAY IMAGESCOPE

FDA 510(k)

FDA Class 2 ·Radiology

COMPACT AUTO-SAFETY INJECTOR (CASI)

FDA 510(k)

FDA Class 2 ·General Hospital

AUTO-SAFETY INJECTOR-2 (ASI-2)

FDA 510(k)

FDA Class 2 ·General Hospital

ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

FDA 510(k)

FDA Class 2 ·Microbiology