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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 6 of 248

Device	Model / Reference	Registries	Class	Status
Genesis-C	2888-259-5	FDA UDI	Class II	Active
Carriere® SLX 3D™	777-LL3-HK-RP	FDA UDI	Class I	Active
Tempra	09E-LR7-400-3	FDA UDI	Class I	Active
Beta Titanium Straight Wire	101-012	FDA UDI	Class I	Active
Band Assemblies	900-109066E-18CW	FDA UDI	Class I	Active
Band Assemblies	950-134091E	FDA UDI	Class I	Active
SLX™ Clear Aligners	128-AL9	FDA UDI	Class II	Active
Sl Pro	780-LR4-HK-10	FDA UDI	Class I	Active
OrthoLite™ Instruments	201-502W	FDA UDI	Class I	Active
Aria	716-357-10	FDA UDI	Class I	Active
Masel	4758-328	FDA UDI	Class I	Active
Nitanium® Super Elastic Archwires	101-441	FDA UDI	Class I	Active
Silhouette	2886-401-5	FDA UDI	Class I	Unknown
Silhouette	2886-458-5	FDA UDI	Class I	Unknown
Elastic Chain	4108-617	FDA UDI	Class I	Active
Band Assemblies	900-109066E-9CW	FDA UDI	Class I	Active
Illusion Plus	700-799Q	FDA UDI	Class I	Unknown
Envision	701-139-5	FDA UDI	Class II	Active
Illusion Plus Silver Slot	700-599MC	FDA UDI	Class I	Active
NeoCrystal Plus	715-235-5	FDA UDI	Class II	Active
Elite	900-1218-375-3	FDA UDI	Class I	Active
Nickel-Free Mini-Twin	4835-451-10	FDA UDI	Class I	Active
Band Assemblies	950-15309E	FDA UDI	Class I	Active
Reveal®	135-RET2	FDA UDI	Class I	Active
NeoCrystal	714-099MCQ	FDA UDI	Class II	Active
Envision	701-198Q	FDA UDI	Class II	Active
Elite	900-01581-310-3	FDA UDI	Class I	Active
Reveal® Clear Aligners	140-8762	FDA UDI	Class II	Active
Tempra	08E-UL6-430-3	FDA UDI	Class I	Active
Nitanium® Super Elastic Archwires	100-596	FDA UDI	Class I	Active
Mini Unicycle™	4120-882	FDA UDI	Class I	Active
Tempra	8E-U6R435-1	FDA UDI	Class I	Active
Band Assemblies	950-156071E-24	FDA UDI	Class I	Active
Band Assemblies	900-10708E-35	FDA UDI	Class I	Active
Elite® Band Assemblies	902-14508E-3	FDA UDI	Class I	Active
Andrews2™	712-807-10	FDA UDI	Class I	Unknown
Palatal Expander2 Appliance	101-766	FDA UDI	Class I	Unknown
Band Assemblies	900-146081E-36	FDA UDI	Class I	Active
Ortho Organizers	407-051S	FDA UDI	Class I	Active
Elite Opti-MIM	702-290-10	FDA UDI	Class I	Unknown
Elite	900-1228-400-3	FDA UDI	Class I	Active
Endura Plus Instruments	201-125	FDA UDI	Class I	Active
Elite® Band Assemblies	900-122081E-41	FDA UDI	Class I	Active
Maestro® Band Assemblies	902-253081E-3	FDA UDI	Class I	Active
Elite® Med-Twin Brackets	707-249HK-10	FDA UDI	Class I	Unknown
Elite® Band Assemblies	900-146063E	FDA UDI	Class I	Active
Reveal® Aligners	572-2560	FDA UDI	Class II	Active
Elite® Med-Twin Brackets	707-313-10	FDA UDI	Class I	Unknown
Mini Unicycle™	4120-522	FDA UDI	Class I	Active
Band Assemblies	069E	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.