Medical device licence · 66423 · Class 3

GC INITIAL

Yes: licensed in Canada

Licence status Issued (active); first licensed November 9, 2004. It is in Health Canada’s list of active licences.

Licence number: 66423
Licence holder: GC America Inc.Alsip, Illinois, United States
Risk class: Class III (moderate to high risk)
Licence type: System
First licensed: November 9, 2004
Devices covered: 150

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

GC INITIAL INMETALBOND
GC INITIAL LF CLEAR WINDOW
GC INITIAL LISI ADVANCED SET
GC INITIAL LISI BASIC SET
GC INITIAL LISI BLEACH DENTIN
GC INITIAL LISI CERVICAL TRANSLUCENT
GC INITIAL LISI CLEAR FLUORESCENCE
GC INITIAL LISI CORRECTION POWDER
GC INITIAL LISI DENTIN
GC INITIAL LISI ENAMEL OCCLUSAL
GC INITIAL LISI ENAMEL OPAL
GC INITIAL LISI FLUO DENTINE
GC INITIAL LISI INSIDE
GC INITIAL LISI MODELING LIQUID
GC INITIAL LISI TRANSLUCENT
GC INITIAL LISI TRANSLUCENT MODIFIER
GC INITIAL LISI, ENAMEL
GC INITIAL MC CHROMA SHADE TRANSLUCENT
GC INITIAL MC CLEAR WINDOW
GC INITIAL MC PASTE OPAQUE CLASSIC LINE
GC INITIAL MC PASTE OPAQUE THINNER
GC INITIAL MC POWDER OPAQUE MODIFIER
GC INITIAL MC/ZR-FS MODELLING LIQUID
GC INITIAL SPECTRUM GLAZE
GC INITIAL SPECTRUM GLAZE POWDER
GC INITIAL SPECTRUM STAIN
GC INITIAL SPECTRUM STAIN SET
GC INITIAL TI CLEAR WINDOW
GC INITIAL ZR CLEAR WINDOW
INITIAL LF BLEACH DENTIN
INITIAL LF BLEACH SET
INITIAL LF CERVICAL TRANSLUCENT
INITIAL LF CLEAR FLUORESCENCE
INITIAL LF CORRECTION POWDER
INITIAL LF DENTIN
INITIAL LF ENAMEL
INITIAL LF ENAMEL INTENSIVE
INITIAL LF ENAMEL OCCLUSAL
INITIAL LF ENAMEL OPAL
INITIAL LF ENTRANCE KIT
INITIAL LF FLUO-DENTIN
INITIAL LF GINGIVAL UNIVERSAL
INITIAL LF GLAZE LIQUID
INITIAL LF INSIDE
INITIAL LF MODELLING LIQUID
INITIAL LF OPAQUE LIQUID
INITIAL LF OPAQUS DENTIN
INITIAL LF OPAQUS DENTIN MOD.
INITIAL LF POWDER OPAQUE
INITIAL LF SET
INITIAL LF SHOULDER LIQUID
INITIAL LF SHOULDER OPAQUE
INITIAL LF SHOULDER TRANSPA
INITIAL LF TRANSLUCENT
INITIAL LF TRANSLUCENT MOD.
INITIAL MC BLEACH DENTIN
INITIAL MC BLEACH ENAMEL
INITIAL MC BLEACH SET
INITIAL MC CERVICAL TRANSLUCENT
INITIAL MC CLEAR FLUORESCENCE
INITIAL MC CORRECTION POWDER
INITIAL MC DENTIN
INITIAL MC ENAMEL
INITIAL MC ENAMEL INTENSIVE
INITIAL MC ENAMEL OCCLUSAL
INITIAL MC ENAMEL OPAL
INITIAL MC ENTRANCE KIT
INITIAL MC FLUO-DENTIN
INITIAL MC GINGIVAL UNIVERSAL
INITIAL MC GLAZE LIQUID
INITIAL MC GLAZE POWDER
INITIAL MC GUM SHADES SET (PASTE OPAQUE)
INITIAL MC GUM SHADES SET (POWDER OPAQUE)
INITIAL MC INSIDE
INITIAL MC MODELLING LIQUID
INITIAL MC OPAQUS DENTIN
INITIAL MC OPAQUS DENTIN MOD.
INITIAL MC PASTE OPAQUE
INITIAL MC PASTE OPAQUE SET
INITIAL MC SET
INITIAL MC SHOULDER
INITIAL MC SHOULDER LIQUID
INITIAL MC SHOULDER OPAQUE
INITIAL MC SHOULDER TRANSPA
INITIAL MC TRANSLUCENT
INITIAL MC TRANSLUCENT MODIFIER
INITIAL MC, GM
INITIAL MC, OPAQUE LIQUID
INITIAL MC, PASTE OPAQUE MODIFIER
INITIAL MC, POWDER OPAQUE
INITIAL TI BLEACH DENTIN
INITIAL TI BLEACH ENAMEL
INITIAL TI BLEACH SET
INITIAL TI BONDER
INITIAL TI CERVICAL TRANSLUCENT
INITIAL TI CLEAR FLUORESCENCE
INITIAL TI CORRECTION POWDER
INITIAL TI DENTIN
INITIAL TI ENAMEL
INITIAL TI ENAMEL INTENSIVE
INITIAL TI ENAMEL OCCLUSAL
INITIAL TI ENAMEL OPAL
INITIAL TI ENTRANCE KIT
INITIAL TI FLUO-DENTIN
INITIAL TI GINGIVAL UNIVERSAL
INITIAL TI GLAZE LIQUID
INITIAL TI GLAZE POWDER
INITIAL TI INSIDE
INITIAL TI MODELLING LIQUID
INITIAL TI OPAQUE LIQUID
INITIAL TI OPAQUS DENTIN
INITIAL TI POWDER OPAQUE
INITIAL TI POWDER OPAQUE MOD.
INITIAL TI SET
INITIAL TI SHOULDER
INITIAL TI SHOULDER LIQUID
INITIAL TI SHOULDER OPAQUE
INITIAL TI SHOULDER TRANSPA
INITIAL TI TRANSLUCENT
INITIAL ZR BLEACH DENTIN
INITIAL ZR BLEACH ENAMEL BL-E
INITIAL ZR BLEACH SET
INITIAL ZR CERVICAL TRANSLUCENT
INITIAL ZR CLEAR FLUORESCENCE
INITIAL ZR CORRECTION POWDER
INITIAL ZR DENTIN
INITIAL ZR ENAMEL
INITIAL ZR ENAMEL INTENSIVE
INITIAL ZR ENAMEL OCCLUSAL
INITIAL ZR ENAMEL OPAL
INITIAL ZR ENTRANCE KIT
INITIAL ZR FLUO-DENTIN
INITIAL ZR FRAME MODIFIER
INITIAL ZR FRAME MODIFIER BL-FM
INITIAL ZR GINGIVAL UNIVERSAL
INITIAL ZR GLAZE LIQUID
INITIAL ZR GLAZE POWDER
INITIAL ZR GUM SHADES SET
INITIAL ZR INSIDE
INITIAL ZR MODELLING LIQUID
INITIAL ZR OPAQUS DENTIN MOD.
INITIAL ZR SET
INITIAL ZR SHOULDER
INITIAL ZR SHOULDER LIQUID
INITIAL ZR SHOULDER OPAQUE
INITIAL ZR SHOULDER TRANSPA
INITIAL ZR TRANSLUCENT
INITIAL ZR TRANSLUCENT MOD.
INITIAL ZR, GM
MC/LF CONNECTOR PASTE

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.