FLEXMEDICS

FLEXMEDICS

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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

Clear

N/A - 10195291000017 Catalog Number :

Device Description : CIM CERAMIC TWIN ROTH .022 L1/2 0°T 0°A

Device Class : 2

Duns Number: 028853567

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

N/A - 10195291000024 Catalog Number :

Device Description : CIM CERAMIC TWIN ROTH .018 L1/2 0°T 0°A

Device Class : 2

Duns Number: 028853567

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

N/A - 10195291000031 Catalog Number :

Device Description : CIM CERAMIC TWIN ROTH .022 LL3 HK -11°T +5°A 2°R

Device Class : 2

Duns Number: 028853567

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

N/A - 10195291000048 Catalog Number :

Device Description : CIM CERAMIC TWIN ROTH .022 LR3 HK -11°T +5°A 2°R

Device Class : 2

Duns Number: 028853567

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

N/A - 10195291000055 Catalog Number :

Device Description : CIM CERAMIC TWIN ROTH .018 LL3 HK -11°T +5°A 2°R

Device Class : 2

Duns Number: 028853567

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

N/A - 10195291000062 Catalog Number :

Device Description : CIM CERAMIC TWIN ROTH .018 LR3 HK -11°T +5°A 2°R

Device Class : 2

Duns Number: 028853567

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

N/A - 10195291000079 Catalog Number :

Device Description : CIM CERAMIC TWIN ROTH .022 LL4 HK -17°T 0°A

Device Class : 2

Duns Number: 028853567

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

N/A - 10195291000086 Catalog Number :

Device Description : CIM CERAMIC TWIN ROTH .022 LR4 HK -17°T 0°A

Device Class : 2

Duns Number: 028853567

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

N/A - 10195291000093 Catalog Number :

Device Description : CIM CERAMIC TWIN ROTH .018 LL4 HK -17°T 0°A

Device Class : 2

Duns Number: 028853567

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

N/A - 10195291000109 Catalog Number :

Device Description : CIM CERAMIC TWIN ROTH .018 LR4 HK -17°T 0°A

Device Class : 2

Duns Number: 028853567

Premarket Exempt : No

Product Code : NJM

Prescription Use : Yes

Device Count : 5

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