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"™ LR Cuspid Roth .018 - 00842452100101 Catalog Number : 710-720T

Device Description : Lower Right Cuspid .018 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 .018 - 00842452100118 Catalog Number : 710-723T

Device Description : Lower Left 1st Bicuspid .018 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 .018 - 00842452100125 Catalog Number : 710-724T

Device Description : Lower Right 1st Bicuspid .018 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 .018 - 00842452100132 Catalog Number : 710-727T

Device Description : Lower Left 2nd Bicuspid .018 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 .018 - 00842452100149 Catalog Number : 710-728T

Device Description : Lower Right 2nd Bicuspid .018 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 Central Roth .022 - 00842452100156 Catalog Number : 710-901T

Device Description : Upper Left Central .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 Central Roth .022 - 00842452100163 Catalog Number : 710-902T

Device Description : Upper Right Central .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 Lateral Roth .022 - 00842452100170 Catalog Number : 710-903T

Device Description : Upper Left Lateral .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 Lateral Roth .022 - 00842452100187 Catalog Number : 710-904T

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

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Comp Plus "T"™ UL Cuspid Roth .022 - 00842452100194 Catalog Number : 710-905T

Device Description : Upper 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

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