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"™ UL Central Roth .018 - 00842452100002 Catalog Number : 710-701T

Device Description : Upper Left Central .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"™ UR Central Roth .018 - 00842452100019 Catalog Number : 710-702T

Device Description : Upper Right Central .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 Lateral Roth .018 - 00842452100026 Catalog Number : 710-703T

Device Description : Upper Left Lateral .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"™ UR Lateral Roth .018 - 00842452100033 Catalog Number : 710-704T

Device Description : Upper Right Lateral .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 Cuspid Roth .018 - 00842452100040 Catalog Number : 710-705T

Device Description : Upper Left 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"™ UR Cuspid Roth .018 - 00842452100057 Catalog Number : 710-706T

Device Description : Upper 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"™ UL Bicuspid Roth .018 - 00842452100064 Catalog Number : 710-709T

Device Description : Upper Left 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"™ UR Bicuspid Roth .018 - 00842452100071 Catalog Number : 710-710T

Device Description : Upper Right 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"™ Lower Anterior Roth .018 - 00842452100088 Catalog Number : 710-715T

Device Description : Lower Anterior .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 Cuspid Roth .018 - 00842452100095 Catalog Number : 710-719T

Device Description : Lower Left 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

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