SUREFLEX FILES

FDA 510(k)

FDA Class 1 ·Dental

CK-NAC 2-VIAL REAGENT W/SUBSTRATE START

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOTAL ETCH GEL

FDA 510(k)

FDA Class 2 ·Dental

DYRACT II RESTORATIVE

FDA 510(k)

FDA Class 2 ·Dental

ENTERSCAN

FDA 510(k)

FDA Class 2 ·Radiology

ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DYRACT(TM) MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

HDL CHOLESTEROL KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SPECTRUM CURING LIGHT POLYMERIZATION UNIT

FDA 510(k)

FDA Class 2 ·Dental

PRIME & BOND DIRECT COMPOSITE BONDING AGENT

FDA 510(k)

FDA Class 2 ·Dental

Chemistry Analyzer Model: ACCENT S120

Device

EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market·1 country

Chemistry Analyzer Model: ACCENT S120

Device

EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

CHEMISTRY ANALYSERS - MODERATE ROUTINE (with ISE mode test/h > 400 and <= 800)

Device

EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

Device

EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

Device

EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)

Device

EU IVDR · Eu Ivd Class A ·PZ CORMAY Spółka Akcyjna·On the market

Matrix

FDA UDI

Synthes GmbH·10887587013817·MATRIX 1.4MM DRILL BIT W/6MM STOP/13MM F/90° SC...

VSP System

FDA UDI

3D SYSTEMS, INC.·00816847020602·A physical template / guide that is positioned ...

IPS

FDA UDI

KLS-Martin L.P.·00888118100719·IMPLANT, MIDFACE/ORTHOG, 00069, TI-6AL-4V

AccuPlan System

FDA UDI

Medcad·00810007630427·MIDFACE RECONSTRUCTION, SURGICAL PLANNING KIT