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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 5 of 248

Device	Model / Reference	Registries	Class	Status
Band Assemblies	900-123082E-30	FDA UDI	Class I	Active
Masel	3400-117	FDA UDI	Class I	Active
Elite	900-02181-350-3	FDA UDI	Class I	Active
Elite	900-17281-370-3	FDA UDI	Class I	Active
Accufit	3211-415	FDA UDI	Class I	Active
Elite® Band Assemblies	900-123081E-39.5	FDA UDI	Class I	Active
Aria	716-490HK-100	FDA UDI	Class I	Unknown
Carriere® Motion Pro™	424-9F3	FDA UDI	Class I	Active
Band Assemblies	900-107061E-5	FDA UDI	Class I	Active
Elite® Buccal Tubes Direct Bond	951-206-10	FDA UDI	Class I	Active
Elite® Mini-Twin® Brackets	705-237HK-10	FDA UDI	Class I	Unknown
Elite® Band Assemblies	900-106081E	FDA UDI	Class I	Active
Elite® Bondable Buccal Tubes	901-024-10	FDA UDI	Class I	Active
Carriere SLX	713-297	FDA UDI	Class I	Active
Elastic Chain	4108-557	FDA UDI	Class I	Unknown
Silhouette	2886-345-5	FDA UDI	Class I	Unknown
Epic	7E-U7L30-1	FDA UDI	Class I	Active
Maestro® Band Assemblies	911-311091E-31	FDA UDI	Class I	Active
Epic	7E-L7L10-1	FDA UDI	Class I	Active
Carriere® SLB™	703-254-10	FDA UDI	Class I	Active
Masel	5011-401	FDA UDI	Class I	Active
Carriere® SLX™	713-353-10-OP	FDA UDI	Class I	Active
Elite®	902-005-10	FDA UDI	Class I	Active
Accufit	3200-365	FDA UDI	Class I	Active
Elite Opti-MIM	702-387HK-10	FDA UDI	Class I	Active
Band Assemblies	911-311071E-17	FDA UDI	Class I	Active
Band Assemblies	900-12208E-33	FDA UDI	Class I	Active
Elite® Bondable Buccal Tubes	901-141-10	FDA UDI	Class I	Unknown
Elite® Band Assemblies	900-123081E-3	FDA UDI	Class I	Active
Coda™ Orthodontic Brackets	721-471-10	FDA UDI	Class I	Unknown
Elite®	900-152-10	FDA UDI	Class I	Active
Illusion Plus International	708-204-10	FDA UDI	Class I	Active
Rumor	306-0302-5	FDA UDI	Class I	Active
Illusion Plus	700-705-5	FDA UDI	Class I	Unknown
Tempra	09E-UR7-390-3	FDA UDI	Class I	Active
Illusion Plus Silver Slot	700-458-5	FDA UDI	Class I	Active
Band Assemblies	900-118086E-37	FDA UDI	Class I	Active
Elite®	950-035-10	FDA UDI	Class I	Active
Elite®	900-043-10	FDA UDI	Class I	Active
Nickel-Free Mini-Twin	4835-484-10	FDA UDI	Class I	Unknown
Masel	4995-916	FDA UDI	Class I	Active
Ortho Organizers	100-413	FDA UDI	Class I	Active
Elite	900-0168-385-3	FDA UDI	Class I	Active
Elite	900-0218-380-3	FDA UDI	Class I	Active
Quantum	2783-287-5	FDA UDI	Class II	Active
Maestro® Band Assemblies	911-362091E-35.5	FDA UDI	Class I	Active
Ring-Ties	400-806	FDA UDI	Class I	Active
Elite® Band Assemblies	900-023061E	FDA UDI	Class I	Active
Elite® Bondable Buccal Tubes	901-150-10	FDA UDI	Class I	Active
Elastic Chain	4108-591	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.