ORTHO SPECIALTIES

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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, Plastic, Orthodontic (DYW) (10)

Premarket Exempt

Clear

Comp Plus "T"™ UR Cuspid Roth .022 - 00842452100200 Catalog Number : 710-906T

Device Description : Upper Right Cuspid .022 Roth Rx Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Comp Plus "T"™ UL Bicuspid Roth .022 - 00842452100217 Catalog Number : 710-909T

Device Description : Upper Left Bicuspid .022 Roth Rx Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Comp Plus "T"™ UR Bicuspid Roth .022 - 00842452100224 Catalog Number : 710-910T

Device Description : Upper Right Bicuspid .022 Roth Rx Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Comp Plus "T"™ Lower Anterior Roth .022 - 00842452100231 Catalog Number : 710-915T

Device Description : Lower Anterior .022 Roth Rx Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Comp Plus "T"™ LL Cuspid Roth .022 - 00842452100248 Catalog Number : 710-919T

Device Description : Lower Left Cuspid .022 Roth Rx Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Comp Plus "T"™ LR Cuspid Roth .022 - 00842452100255 Catalog Number : 710-920T

Device Description : Lower Right Cuspid .022 Roth Rx Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Comp Plus "T"™ LL 1st Bicuspid Roth .022 - 00842452100262 Catalog Number : 710-923T

Device Description : Lower Left 1st Bicuspid .022 Roth Rx Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Comp Plus "T"™ LR 1st Bicuspid Roth .022 - 00842452100279 Catalog Number : 710-924T

Device Description : Lower Right 1st Bicuspid .022 Roth Rx Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Comp Plus "T"™ LL 2nd Bicuspid Roth .022 - 00842452100286 Catalog Number : 710-927T

Device Description : Lower Left 2nd Bicuspid .022 Roth Rx Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Comp Plus "T"™ LR 2nd Bicuspid Roth .022 - 00842452100293 Catalog Number : 710-928T

Device Description : Lower Right 2nd Bicuspid .022 Roth Rx Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

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