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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 1 of 2

Device	Model / Reference	Registries	Class	Status
Locktight™ Auto Mix Band Cement Natural	600-401	FDA UDI	Class II	Active
.022 Comp Clear Six™ Brackets-1 Case Kit	710-550	FDA UDI	Class II	Active
Adhere™ Light Cure Adhesive 5g Syringe	600-369	FDA UDI	Class II	Active
Comp Plus "T"™ UR Bicuspid Roth .022	710-910T	FDA UDI	Class II	Active
Allgilloid Plus™ Chromatic Mint Alginate	600-643M	FDA UDI	Class II	Active
Comp Plus "T"™ UR Central Roth .022	710-902T	FDA UDI	Class II	Active
Hawaiian Print Class III Adjustable Facemask	600-526	FDA UDI	Class II	Active
Flames Class III Adjustable Facemask	600-527	FDA UDI	Class II	Active
Saftey Release Modules Medium	600-558	FDA UDI	Class II	Active
Adhere™ Enamel Etch Conditioner	600-373	FDA UDI	Class II	Active
Comp Plus "T"™ LL 2nd Bicuspid Roth .018	710-727T	FDA UDI	Class II	Active
American Flag Class III Adjustable Facemask	600-525	FDA UDI	Class II	Active
Composite Clear Eyelets	600-334	FDA UDI	Class II	Active
Comp Plus "T"™ UR Central Roth .018	710-702T	FDA UDI	Class II	Active
Comp Plus "T"™ LL Cuspid Roth .022	710-919T	FDA UDI	Class II	Active
.022 UL Cuspid Comp Clear Six™	710-605	FDA UDI	Class II	Active
Comp Plus "T"™ UL Lateral Roth .018	710-703T	FDA UDI	Class II	Active
LockTight™ Auto Mix Band Cement Blue	600-400	FDA UDI	Class II	Active
Comp Plus "T"™ UR Bicuspid Roth .018	710-710T	FDA UDI	Class II	Active
Comp Plus "T"™ LL 1st Bicuspid Roth .018	710-723T	FDA UDI	Class II	Active
Adhere™ Self Cure Adhesive Kit	600-385	FDA UDI	Class II	Active
Comp Plus Six™ 1 Case Lower Bracket Kit-Lab Use	720-562	FDA UDI	Class II	Active
.022 UR Central Comp Clear Six™	710-602	FDA UDI	Class II	Active
Safety Release Modules Heavy	600-559	FDA UDI	Class II	Active
.022 UR Cuspid Comp Clear Six™	710-606	FDA UDI	Class II	Active
.022 LR Cuspid Comp Clear Six™	710-620	FDA UDI	Class II	Active
Comp Plus "T"™ Lower Anterior Roth .022	710-915T	FDA UDI	Class II	Active
Comp Plus "T"™ UL Cuspid Roth .022	710-905T	FDA UDI	Class II	Active
.022 LL Cuspid Comp Clear Six™	710-619	FDA UDI	Class II	Active
Adhere™ Light Cure Adhesive Tips	600-371	FDA UDI	Class II	Active
.022 UL Lateral Comp Clear Six™	710-603	FDA UDI	Class II	Active
Comp Plus "T"™ LL 2nd Bicuspid Roth .022	710-927T	FDA UDI	Class II	Active
Adhere™ Self Cure Adhesive Tips	600-386	FDA UDI	Class II	Active
Comp Plus "T"™ UL Central Roth .018	710-701T	FDA UDI	Class II	Active
Adhere™ Light Cure Adhesive Kit	600-370	FDA UDI	Class II	Active
Comp Plus "T"™ UL Central Roth .022	710-901T	FDA UDI	Class II	Active
Comp Plus "T"™ UL Lateral Roth .022	710-903T	FDA UDI	Class II	Active
Comp Plus "T"™ LR 2nd Bicuspid Roth .018	710-728T	FDA UDI	Class II	Active
Comp Plus "T"™ LR Cuspid Roth .022	710-920T	FDA UDI	Class II	Active
Safety Release Modules Light	600-557	FDA UDI	Class II	Active
Comp Plus "T"™ LR 1st Bicuspid Roth .018	710-724T	FDA UDI	Class II	Active
Adhere™ Self Cure Activator	600-387	FDA UDI	Class II	Active
Comp Plus "T"™ UR Lateral Roth .018	710-704T	FDA UDI	Class II	Active
Comp Plus "T"™ LR 2nd Bicuspid Roth .022	710-928T	FDA UDI	Class II	Active
.022 Universal Bicuspid Comp Clear Six™	710-611	FDA UDI	Class II	Active
Comp Plus "T"™ Lower Anterior Roth .018	710-715T	FDA UDI	Class II	Active
Comp Plus "T"™ LL Cuspid Roth .018	710-719T	FDA UDI	Class II	Active
Allgilloid Plus™ Chromatic Cherry Alginate	600-643C	FDA UDI	Class II	Active
Comp Plus "T"™ UL Cuspid Roth .018	710-705T	FDA UDI	Class II	Active
.022 UR Lateral Comp Clear Six™	710-604	FDA UDI	Class II	Active

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