Gc Orthodontics America Inc.

Address:3737 W. 127th Street,Alsip,IL,60803,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN (DYH) (6) BAND, ELASTIC, ORTHODONTIC (ECI) (3) WIRE, ORTHODONTIC (DZC) (1)

Premarket Exempt

No Yes

Clear

GC Ortho Chain - E53586202000011 Catalog Number : 86-2020-0001

Device Description : GC ORTHO CHAIN Grey Medium

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

GC Ortho Chain - E53586203000001 Catalog Number : 86-2030-0000

Device Description : GC ORTHO CHAIN GREY LONG 2M

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

GC Ortho Chain - E53586203000011 Catalog Number : 86-2030-0001

Device Description : GC ORTHO CHAIN Grey Long

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : ECI

Prescription Use : Yes

Device Count : 1

GC Ortho ConnectTM - E53590110000001 Catalog Number : 90-1100-0000

Device Description : GC Ortho ConnectTM 2 syringe pack

Device Class : 2

Duns Number: 063167128

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

GC KommonBaseTM - E53590120000001 Catalog Number : 90-1200-0000

Device Description : GC KommonBaseTM HV Clear 2 syringe pack

Device Class : 2

Duns Number: 063167128

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

GC KommonBaseTM - E53590130000001 Catalog Number : 90-1300-0000

Device Description : GC KommonBaseTM LV Pink 2 syringe pack

Device Class : 2

Duns Number: 063167128

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

GC Ortho Etching Gel - E53590140000001 Catalog Number : 90-1400-0000

Device Description : GC Ortho Etching Gel 2 syringe pack

Device Class : 2

Duns Number: 063167128

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

GC Ortho Connect™ - E53590310000001 Catalog Number : 90-3100-0000

Device Description : GC Ortho Connect™ Flow

Device Class : 2

Duns Number: 063167128

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

GC Aligner Connect - E53590410000001 Catalog Number : 90-4100-0000

Device Description : GC Aligner Connect

Device Class : 2

Duns Number: 063167128

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Labial Bow - E53592012000541 Catalog Number : 92-0120-0054

Device Description : Labial Bow Standard 54mm

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

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