Gc Orthodontics America Inc.

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

Bracket, ceramic, orthodontic (NJM) (9) BRACKET, METAL, ORTHODONTIC (EJF) (1)

Premarket Exempt

No Yes

Clear

GEM - D788092C0500101 Catalog Number : 09-2C05-0010

Device Description : GEM Roth 022 U 5-5 HK 3,4,5

Device Class : 1

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : EJF

Prescription Use : Yes

Device Count : 1

Experience - D78811111000071 Catalog Number : 11-1110-0007

Device Description : Exp C ACO 018/UR1 12T 5A

Device Class : 2

Duns Number: 063167128

Premarket Exempt : Yes

Product Code : NJM

Prescription Use : Yes

Device Count : 1

Experience - D78811111000101 Catalog Number : 11-1110-0010

Device Description : EXC ROTH 018/UR1 12T 5A

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811111000201 Catalog Number : 11-1110-0020

Device Description : EXC MBT 018/UR1 17T 4A

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811111000301 Catalog Number : 11-1110-0030

Device Description : EXC XT 018/UR1 18T 5A

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811112000101 Catalog Number : 11-1120-0010

Device Description : EXC ROTH 018/UR2 8T 9A

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811112000201 Catalog Number : 11-1120-0020

Device Description : EXC MBT 018/UR2 10T 8A

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811112000301 Catalog Number : 11-1120-0030

Device Description : EXC XT 018/UR2 10T 8A

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811113000101 Catalog Number : 11-1130-0010

Device Description : EXC ROTH 018/UR3 -2T 13A 4M

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811113000301 Catalog Number : 11-1130-0030

Device Description : EXC XT 018/UR3 0T 8A 2M

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

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