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 - D78811121000101 Catalog Number : 11-1210-0010

Device Description : EXC ROTH 018/UL1 12T 5A

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811121000201 Catalog Number : 11-1210-0020

Device Description : EXC MBT 018/UL1 17T 4A

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811121000301 Catalog Number : 11-1210-0030

Device Description : EXC XT 018/UL1 18T 5A

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811122000101 Catalog Number : 11-1220-0010

Device Description : EXC ROTH 018/UL2 8T 9A

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811122000201 Catalog Number : 11-1220-0020

Device Description : EXC MBT 018/UL2 10T 8A

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811122000301 Catalog Number : 11-1220-0030

Device Description : EXC XT 018/UL2 10T 8A

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811123000101 Catalog Number : 11-1230-0010

Device Description : EXC ROTH 018/UL3 -2T 13A 4M

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811123000301 Catalog Number : 11-1230-0030

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

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811123D00101 Catalog Number : 11-123D-0010

Device Description : EXC ROTH 018/UL3 -2T 13A 4M HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

Experience - D78811123D00201 Catalog Number : 11-123D-0020

Device Description : EXC MBT 018/UL3 -7T 8A HK

Device Class :

Duns Number: 063167128

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

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