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

.022 UL Central Comp Clear Six™ - 00842452100309 Catalog Number : 710-601

Device Description : Upper Left Central .022 Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

.022 UR Central Comp Clear Six™ - 00842452100316 Catalog Number : 710-602

Device Description : Upper Right Central .022 Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

.022 UL Lateral Comp Clear Six™ - 00842452100323 Catalog Number : 710-603

Device Description : Upper Left Lateral .022 Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

.022 UR Lateral Comp Clear Six™ - 00842452100330 Catalog Number : 710-604

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

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

.022 UL Cuspid Comp Clear Six™ - 00842452100347 Catalog Number : 710-605

Device Description : Upper Left Cuspid .022 Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

.022 UR Cuspid Comp Clear Six™ - 00842452100354 Catalog Number : 710-606

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

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

.022 Universal Bicuspid Comp Clear Six™ - 00842452100361 Catalog Number : 710-611

Device Description : Universal Bicuspid .022 Direct Bond Composite Orthodontic Bracket

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

.022 Lower Anterior Comp Clear Six™ - 00842452100378 Catalog Number : 710-615

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

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

.022 LL Cuspid Comp Clear Six™ - 00842452100385 Catalog Number : 710-619

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

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

.022 LR Cuspid Comp Clear Six™ - 00842452100392 Catalog Number : 710-620

Device Description : Lower Right Cuspid .022 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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