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) (10)

Premarket Exempt

No Yes

Clear

Experience - D78811143000101 Catalog Number : 11-1430-0010

Device Description : EXC ROTH 018/LR3 -11T 7A 2M

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811143000301 Catalog Number : 11-1430-0030

Device Description : EXC XT 018/LR3 -3T 7A 2M

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811143D00101 Catalog Number : 11-143D-0010

Device Description : EXC ROTH 018/LR3 -11T 7A 2M HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811143D00201 Catalog Number : 11-143D-0020

Device Description : EXC MBT 018/LR3 -6T 3A HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811143D00211 Catalog Number : 11-143D-0021

Device Description : EXC MBT 018/LR3 0T 3A 0OF HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811143D00301 Catalog Number : 11-143D-0030

Device Description : EXC XT 018/LR3 -3T 7A 2M HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D788111440Z0101 Catalog Number : 11-1440-Z010

Device Description : EXZ ROTH 018/LR4 -17T 0A 4D

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811144DZ0101 Catalog Number : 11-144D-Z010

Device Description : EXZ ROTH 018/LR4 -17T 0A 4D HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D788111450Z0101 Catalog Number : 11-1450-Z010

Device Description : EXZ ROTH 018/LR5 -22T 0A 4D

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811145DZ0101 Catalog Number : 11-145D-Z010

Device Description : EXZ ROTH 018/LR5 -22T 0A 4D HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

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