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ORTHO SPECIALTIES

Last updated May 24, 2026

What ORTHO SPECIALTIES makes

Ortho Specialties manufactures single-use plastic orthodontic brackets, including clear and colored variants for fixed appliances, as well as adhesive systems for bracket bonding. Their portfolio also includes extraoral headgear and facemasks for orthodontic treatment, along with dental impression materials for creating patient molds. Additional products encompass orthodontic bonding agents and enamel conditioners designed for bracket application.

The company’s devices are classified under FDA regulations as Class I and Class II, with most requiring 510(k) clearance or inclusion in the FDA’s UdL (Updated Device List). Products are listed in the FDA’s 510(k) and UdL registries, adhering to U.S. medical device compliance standards. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: orthospecialties.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800-637-1237
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 011050583

Catalogue (69)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Comp Plus "T"™ UL Bicuspid Roth .018	710-709T	FDA UDI	Class II	Active
Comp Plus "T"™ UL Bicuspid Roth .022	710-909T	FDA UDI	Class II	Active
.022 Comp Clear Six™ Brackets-5 Case Kit	710-500	FDA UDI	Class II	Active
.022 Lower Anterior Comp Clear Six™	710-615	FDA UDI	Class II	Active
Multi-Adjustable Facemask	600-524	FDA UDI	Class II	Active
Leopard Print Class III Adjustable Facemask	600-528	FDA UDI	Class II	Active
.022 UL Central Comp Clear Six™	710-601	FDA UDI	Class II	Active
Comp Plus "T"™ UR Cuspid Roth .018	710-706T	FDA UDI	Class II	Active
Comp Plus "T"™ LL 1st Bicuspid Roth .022	710-923T	FDA UDI	Class II	Active
Adhere™ Self Cure Adhesive 5g Syringe	600-388	FDA UDI	Class II	Active
Comp Plus "T"™ UR Lateral Roth .022	710-904T	FDA UDI	Class II	Active
Comp Plus "T"™ UR Cuspid Roth .022	710-906T	FDA UDI	Class II	Active
Comp Plus "T"™ LR Cuspid Roth .018	710-720T	FDA UDI	Class II	Active
Comp Plus Six™ 1 Case Bracket Kit-Lab Use	720-560	FDA UDI	Class II	Active
Adhere™ Light Cure Adhesive Primer	600-372	FDA UDI	Class II	Active
Comp Plus Six™ 1 Case Upper Bracket Kit-Lab Only	720-561	FDA UDI	Class II	Active
Comp Plus "T"™ LR 1st Bicuspid Roth .022	710-924T	FDA UDI	Class II	Active
Regency Tube	K936243	FDA 510(k)	Class I	Active
Composite Orthodontic Brackets	K140807	FDA 510(k)	Class II	Active

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