G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER

FDA 510(k)

FDA Class 2 ·Dental

UNIFAST LC

FDA 510(k)

FDA Class 2 ·Dental

FUJI LINING CEMENT LIGHT CURE

FDA 510(k)

FDA Class 2 ·Dental

MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES

FDA 510(k)

FDA Class 2 ·Dental

RESUBMITTED EMA DENTIN CEMENT

FDA 510(k)

FDA Class 2 ·Dental

76 ELW BITE CHECKER SILICONE

FDA 510(k)

FDA Class 2 ·Dental

EXAMIX DISPENSER

FDA 510(k)

FDA Class 1 ·Dental

TOOTH SHADE RESIN

FDA 510(k)

FDA Class 2 ·Dental

LIMI ALLOY

FDA 510(k)

FDA Class 2 ·Dental

DENTURE RESIN

FDA 510(k)

FDA Class 2 ·Dental

G-CERA PORCELAIN BOND

FDA 510(k)

FDA Class 2 ·Dental

EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL

FDA 510(k)

FDA Class 2 ·Radiology

GC CERVICAL CEMENT

FDA 510(k)

FDA Class 2 ·Dental

FUJI II LC

FDA 510(k)

FDA Class 2 ·Dental

76 EMA LINING CEMENT

FDA 510(k)

FDA Class 2 ·Dental

SURFLEX F

FDA 510(k)

FDA Class 2 ·Dental

FUJI CAP II CAPSULE & APPLIER

FDA 510(k)

FDA Class 2 ·Dental

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY ON THE MODULAR ANALYSTICS E170 IMMUNOASSAY ANALYZER

HGI Europe Oy

Importer

🇫🇮 Finland·2 Manufacturers

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit