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) (6) Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (4)

Premarket Exempt

Clear

.022 Comp Clear Six™ Brackets-5 Case Kit - 00842452100408 Catalog Number : 710-500

Device Description : 5 Patient Set Of Composite Direct Bond Brackets And Stainless Steel Molar Tubes

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

.022 Comp Clear Six™ Brackets-1 Case Kit - 00842452100415 Catalog Number : 710-550

Device Description : 1 Patient Set Of Composite Direct Bond Brackets And Stainless Steel Molar Tubes

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Comp Plus Six™ 1 Case Bracket Kit-Lab Use - 00842452100446 Catalog Number : 720-560

Device Description : 1 Set Of .022 Upper and Lower Direct Bond Composite Brackets With Stainless Stee 1 Set Of .022 Upper and Lower Direct Bond Composite Brackets With Stainless Steel Molar Tubes

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Comp Plus Six™ 1 Case Upper Bracket Kit-Lab Only - 00842452100453 Catalog Number : 720-561

Device Description : 1 Set Of Upper Direct Bond Composite Brackets With Stainless Steel Molar Tubes

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Comp Plus Six™ 1 Case Lower Bracket Kit-Lab Use - 00842452100460 Catalog Number : 720-562

Device Description : 1 Set Of Lower Direct Bond Composite Brackets With Stainless Steel Molar Tubes

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Composite Clear Eyelets - 00842452100484 Catalog Number : 600-334

Device Description : Direct Bond Composite Orthodontic Eyelet

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYW

Prescription Use : Yes

Device Count : 1

Adhere™ Light Cure Adhesive 5g Syringe - 00842452100491 Catalog Number : 600-369

Device Description : Light Cure Adhesive Paste In Syringe For Direct Bonding Orthodontic Brackets

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Adhere™ Light Cure Adhesive Kit - 00842452100507 Catalog Number : 600-370

Device Description : Light Cure Adhesive Kit For Direct Bonding Orthodontic Brackets

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Adhere™ Light Cure Adhesive Tips - 00842452100514 Catalog Number : 600-371

Device Description : Light Cure Adhesive Preloaded Tips For Direct Bonding Orthodontic Brackets

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

Adhere™ Light Cure Adhesive Primer - 00842452100521 Catalog Number : 600-372

Device Description : Light Cure Adhesive Primer For Direct Bonding Orthodontic Brackets

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DYH

Prescription Use : Yes

Device Count : 1

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