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

Adhesive, Bracket And Tooth Conditioner, Resin (DYH) (4) Headgear, Extraoral, Orthodontic (DZB) (3) Material, Tooth Shade, Resin (EBF) (3)

Premarket Exempt

Clear

Adhere™ Enamel Etch Conditioner - 00842452100538 Catalog Number : 600-373

Device Description : Phosphoric Acid Etch For Direct Bonding Orthodontic Brackets

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Adhere™ Self Cure Adhesive Kit - 00842452100545 Catalog Number : 600-385

Device Description : Self Curing 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™ Self Cure Adhesive Tips - 00842452100552 Catalog Number : 600-386

Device Description : Self Curing 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™ Self Cure Activator - 00842452100569 Catalog Number : 600-387

Device Description : Self Curing 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

Adhere™ Self Cure Adhesive 5g Syringe - 00842452100576 Catalog Number : 600-388

Device Description : Self Curing 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

LockTight™ Auto Mix Band Cement Blue - 00842452100583 Catalog Number : 600-400

Device Description : Glass Ionomer Cement For Orthodontic Bands-Blue Color

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Locktight™ Auto Mix Band Cement Natural - 00842452100590 Catalog Number : 600-401

Device Description : Glass Ionomer Cement For Orthodontic Bands-Natural Color

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Multi-Adjustable Facemask - 00842452100606 Catalog Number : 600-524

Device Description : Adjustable Reverse Pull Headgear With Center Bar For Class III Treatment

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

American Flag Class III Adjustable Facemask - 00842452100613 Catalog Number : 600-525

Device Description : Adjustable Reverse Pull Headgear With Center Bar For Class III Treatment

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

Hawaiian Print Class III Adjustable Facemask - 00842452100620 Catalog Number : 600-526

Device Description : Adjustable Reverse Pull Headgear With Center Bar For Class III Treatment

Device Class : 2

Duns Number: 011050583

Premarket Exempt : No

Product Code : DZB

Prescription Use : Yes

Device Count : 1

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