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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

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 1 of 248

Device	Model / Reference	Registries	Class	Status
Maestro® Band Assemblies	902-354083E-3	FDA UDI	Class I	Active
Envision	701-185HK-5	FDA UDI	Class II	Active
Reveal® Clear Aligners	140-8775	FDA UDI	Class II	Active
Tempra	8E-L6R30-1	FDA UDI	Class I	Active
DiMIM® Mini-Twin® Brackets	702-892HK-10	FDA UDI	Class I	Active
SLX® Clear Aligners	128-AL71	FDA UDI	Class II	Active
Mini-Ties	400-509	FDA UDI	Class I	Active
Carriere® SLX 3D™	977-LL7-HK-10	FDA UDI	Class I	Active
Elite® Opti-MIM® Mini-Twin®	702-333-10	FDA UDI	Class I	Unknown
Elite® Band Assemblies	900-133063E-3	FDA UDI	Class I	Active
Cu Nitanium® Archwires	109-368	FDA UDI	Class I	Unknown
Mini-Ties	400-540	FDA UDI	Class I	Unknown
Maestro	711-290HK-10	FDA UDI	Class I	Active
Accufit	3208-300	FDA UDI	Class I	Active
Elite® Band Assemblies	902-153066E-3	FDA UDI	Class I	Active
Smile Safari™ Clear Elastic	401-065S	FDA UDI	Class I	Active
Aria	716-370HK-100	FDA UDI	Class I	Unknown
NeoLucent Plus	704-233-5	FDA UDI	Class II	Active
Elastic Chain	400-190	FDA UDI	Class I	Unknown
Nickel-Free Mini-Twin	4835-426-10	FDA UDI	Class I	Active
Aria Expressions	716-358CH-HK-10	FDA UDI	Class I	Active
Reveal® Clear Aligners	140-8786	FDA UDI	Class II	Active
Elite® Mini-Twin® Brackets	705-399Q	FDA UDI	Class I	Active
Endura® Plus™	204-101	FDA UDI	Class I	Active
Mini Unicycle™	4120-906	FDA UDI	Class I	Active
Elite	900-1228-415-3	FDA UDI	Class I	Active
Masel	4831-5187	FDA UDI	Class I	Active
Cu Nitanium® Archwires	109-363	FDA UDI	Class I	Unknown
Carriere® SLX™	713-224-10-OP	FDA UDI	Class I	Active
Carriere® SLX™	713-393-10-OP	FDA UDI	Class I	Active
DiMIM® Mini-Twin® Brackets	702-849Q	FDA UDI	Class I	Active
Silhouette	2886-374-5	FDA UDI	Class I	Unknown
Stainless Steel Bright Pro Form™ Archwire	100-149	FDA UDI	Class I	Active
Masel	5011-605	FDA UDI	Class I	Active
Elite	900-02181-335-3	FDA UDI	Class I	Active
Elite	900-12181-355-3	FDA UDI	Class I	Active
Tempra	08E-LR6-300-3	FDA UDI	Class I	Active
Epic	7E-L7L35-1	FDA UDI	Class I	Active
Masel	4994-207	FDA UDI	Class I	Active
Elite® Band Assemblies	900-004082E-3	FDA UDI	Class I	Active
Tempra	09E-LR7-310-3	FDA UDI	Class I	Active
Band Assemblies	900-10908E-34.5	FDA UDI	Class I	Active
Bravo Primo	4499-332-10	FDA UDI	Class I	Unknown
Masel	4208-879	FDA UDI	Class I	Active
ClassOne	874-0116	FDA UDI	Class II	Active
Epic	6E-L6R30-1	FDA UDI	Class I	Active
Band Assemblies	950-155071E-22	FDA UDI	Class I	Active
Delta Force®	702-909PH-10	FDA UDI	Class I	Unknown
Band Assemblies	900-123082E-38.5	FDA UDI	Class I	Active
Ortho Organizers	105-020	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.

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.