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 - D78811123D00211 Catalog Number : 11-123D-0021

Device Description : EXC MBT 018/UL3 0T 8A 0OF HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811123D00301 Catalog Number : 11-123D-0030

Device Description : EXC XT 018/UL3 0T 8A 2M HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811124000101 Catalog Number : 11-1240-0010

Device Description : EXC ROTH 018/UL4&5 -7T 0A 2D

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811124000301 Catalog Number : 11-1240-0030

Device Description : EXC XT 018/UL4&5 -10T 4A 2D

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811124D00101 Catalog Number : 11-124D-0010

Device Description : EXC ROTH 018/UL4&5 -7T 0A 2D HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811124D00201 Catalog Number : 11-124D-0020

Device Description : EXC MBT 018/UL4&5 -7T 0A HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811124D00301 Catalog Number : 11-124D-0030

Device Description : EXC XT 018/UL4&5 -10T 4A 2D HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811125D00201 Catalog Number : 11-125D-0020

Device Description : EXC MBT 018/UL5 -7T 0A HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811131000101 Catalog Number : 11-1310-0010

Device Description : EXC ROTH 018/LL1&2 -1T 2A

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811133000101 Catalog Number : 11-1330-0010

Device Description : EXC ROTH 018/LL3 -11T 7A 2M

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

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