Is this your brand? Sign in to claim ownership.

Ortho Organizers, Inc.

United States·US-MF-000010061

Last updated September 17, 2026

About

Henry Schein Orthodontics aims to deliver next generation orthodontic solutions to help you provide exceptional clinical outcomes.

From the manufacturer's own website. Source

What Ortho Organizers, Inc. makes

Ortho Organizers, Inc. manufactures orthodontic appliances including metal and ceramic brackets, metal bands, archwires, ligatures, tubes, inter-arch elastic bands, and clear aligners for progressive tooth movement.

The company’s products are classified as Class I and Class II devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

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

Information

Country: United States
Address: 800, King George Blvd, Savannah, United States
Website: henryscheinortho.com/
LinkedIn: linkedin.com/company/henry-schein-orthodontics
Facebook: facebook.com/henryscheinortho
Email: [email protected]
Phone: +1 760 448 8600
PRRC Contact: Nicole Rajek
EUDAMED SRN: US-MF-000010061
FDA FEI Number: 2081322
DUNS Number: —

Catalogue (12364)

Page 8 of 248

Device	Model / Reference	Registries	Class	Status
DiMIM® Mini-Twin® Brackets	702-804-100	FDA UDI	Class I	Active
Andrews2™	712-854T2-10	FDA UDI	Class I	Active
Tempra	9E-U7L36-1	FDA UDI	Class I	Active
Elite® Mini-Twin® Brackets	705-573-10	FDA UDI	Class I	Active
Elite® Band Assemblies	900-10608E-3	FDA UDI	Class I	Active
Direct Bondable Lingual Retainer Wire	433-040	FDA UDI	Class I	Active
Andrews2™	712-857T2-10	FDA UDI	Class I	Active
Elite® Mini-Twin® Band Assemblies	805-39205-3	FDA UDI	Class I	Unknown
DiMIM® Mini-Twin® Brackets	702-848MCQ	FDA UDI	Class I	Active
Reveal® Aligners	572-2543	FDA UDI	Class II	Active
Band Assemblies	902-11108E-39.5	FDA UDI	Class I	Active
Elite® Band Assemblies	900-02408E	FDA UDI	Class I	Active
Masel	4994-712	FDA UDI	Class I	Active
Elite	900-02181-295-3	FDA UDI	Class I	Active
Stainless Steel Braided Pro Form™ Archwires	100-385	FDA UDI	Class I	Active
Orthodontic Instrument	200-307	FDA UDI	Class I	Active
Nickel-Free Mini-Twin	4494-350-10	FDA UDI	Class I	Unknown
O-Ties	400-791	FDA UDI	Class I	Unknown
NeoCrystal Plus	715-389-5	FDA UDI	Class II	Active
Band Assemblies	052	FDA UDI	Class I	Active
Carriere® SLX 3D™	776-KITM-HKS	FDA UDI	Class II	Active
Masel	4994-409	FDA UDI	Class I	Active
Tempra	08E-LR6-370-3	FDA UDI	Class I	Active
Tempra	09E-LL7-390-3	FDA UDI	Class I	Active
Illusion Plus Silver Slot	700-457-5	FDA UDI	Class I	Active
Maestro	711-NSTL	FDA UDI	Class I	Active
Band Assemblies	911-312071E-3	FDA UDI	Class I	Active
Unicycle™	4119-867	FDA UDI	Class I	Active
Masel	4984-3517	FDA UDI	Class I	Active
Maestro® Band Assemblies	911-311091E-32	FDA UDI	Class I	Active
Maestro® Band Assemblies	902-201083E	FDA UDI	Class I	Active
Elite® Bondable Buccal Tubes	901-046-10	FDA UDI	Class I	Active
Coda™ Orthodontic Brackets	721-372-10	FDA UDI	Class I	Unknown
Maestro® Band Assemblies	911-311091E-42.5	FDA UDI	Class I	Active
Band Assemblies	902-104061E	FDA UDI	Class I	Active
Palatal Bar	033-193	FDA UDI	Class I	Unknown
SLX™ Clear Aligners	128-EXP	FDA UDI	Class II	Active
Stainless Steel Archwires	100-161	FDA UDI	Class I	Unknown
Elite	900-16581-305-3	FDA UDI	Class I	Active
Elite	900-1718-315-3	FDA UDI	Class I	Active
Genesis-C	2889-260-10	FDA UDI	Class II	Active
Bravo Primo	4499-912Q	FDA UDI	Class I	Unknown
Maestro	711-258HK-10	FDA UDI	Class I	Active
Carriere	424-912CN	FDA UDI	Class I	Unknown
Elastic Chain	400-315	FDA UDI	Class I	Active
DiMIM® Mini-Twin® Brackets	702-893-10	FDA UDI	Class I	Active
Facemask	426-058	FDA UDI	Class II	Active
Mini-O-Ties™ Ligature Ties	400-721	FDA UDI	Class I	Unknown
Band Assemblies	900-121061E-13	FDA UDI	Class I	Active
Band Assemblies	900-118086E-38.5	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

mdi Europa GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Ortho Organizers, Inc. has three recall records, all initiated between November 1, 2010, and April 2, 2019, with each listed as terminated. The reasons provided in the records include mislabeling of products as nickel-free and an orthodontic bracket being incorrectly labeled.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 2, 2019	Z-2477-2020	—	terminated	Orthodontic Bracket is mislabeled
Apr 2, 2019	Z-2478-2020	—	terminated	Orthodontic Bracket is mislabeled
Nov 1, 2010	Z-1246-2011	—	terminated	Products were mis-labeled as nickel free.