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Sign in to claim this brandOrtho 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/
- facebook.com/henryscheinortho
- [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 10 of 248| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Elite® Band Assemblies | 900-011092E-3 | FDA UDI | Class I | Active |
| Elite® Mini-Twin® Band Assemblies | 805-393055-3 | FDA UDI | Class I | Active |
| ClearArc Aligners | 130-RMA | FDA UDI | Class II | Unknown |
| Epic | 6E-L6L14-1 | FDA UDI | Class I | Active |
| Elite® Band Assemblies | 900-133083E | FDA UDI | Class I | Active |
| Masel | 4984-4107 | FDA UDI | Class I | Active |
| Maestro® | 911-211-10 | FDA UDI | Class I | Active |
| Masel | 4994-205 | FDA UDI | Class I | Active |
| Genesis-C | 2889-290-10 | FDA UDI | Class II | Active |
| Tempra | 9E-U7L385-1 | FDA UDI | Class I | Active |
| Band Assemblies | 911-311071E-7 | FDA UDI | Class I | Active |
| Carriere® SLX™ | 713-356-10-OP | FDA UDI | Class I | Active |
| Band Assemblies | 911-312071E-31 | FDA UDI | Class I | Active |
| Band Assemblies | 902-101086E-43.5 | FDA UDI | Class I | Active |
| Band Assemblies | 900-12408E-31.5 | FDA UDI | Class I | Active |
| Ortho Organizers | 400-300 | FDA UDI | Class I | Unknown |
| Elastic Chain | 4108-610 | FDA UDI | Class I | Unknown |
| Ortho Organizers | 300-021 | FDA UDI | Class I | Active |
| Maestro® Band Assemblies | 911-312091E-35 | FDA UDI | Class I | Active |
| Band Assemblies | 900-123061E-33 | FDA UDI | Class I | Active |
| Carriere® SLX 3D™ | 776-KITCM-HKS | FDA UDI | Class II | Active |
| Elite® Band Assemblies | 900-121061E | FDA UDI | Class I | Active |
| Masel | 4999-412 | FDA UDI | Class I | Active |
| Solstice | 4495-316-10 | FDA UDI | Class I | Unknown |
| O-Ties | 400-796 | FDA UDI | Class I | Unknown |
| Accufit | 3211-430 | FDA UDI | Class I | Active |
| Elite® Med-Twin Brackets | 707-259-10 | FDA UDI | Class I | Unknown |
| Elite® Band Assemblies | 900-127086E | FDA UDI | Class I | Active |
| Elite® Buccal Tubes Direct Bond | 951-154-10 | FDA UDI | Class I | Active |
| NeoCrystal Plus | 715-287HK-5 | FDA UDI | Class II | Active |
| Silhouette | 2886-387-5 | FDA UDI | Class I | Unknown |
| Elastic Chain | 4108-524 | FDA UDI | Class I | Unknown |
| Masel | 4821-114 | FDA UDI | Class I | Active |
| Elastic Chain | 4108-703 | FDA UDI | Class I | Unknown |
| Reveal® Clear Aligners | 573-2582 | FDA UDI | Class II | Active |
| Elastic Chain | 400-347C | FDA UDI | Class I | Active |
| Aria | 716-388-10 | FDA UDI | Class I | Active |
| Rumor | 306-2207-5 | FDA UDI | Class I | Active |
| NeoLucent Plus | 704-272HK-5 | FDA UDI | Class II | Active |
| Ring-Ties | 400-802 | FDA UDI | Class I | Active |
| Tempra | 8E-L6R34-1 | FDA UDI | Class I | Active |
| Band Assemblies | 900-10708E-40 | FDA UDI | Class I | Active |
| Elite | 900-11681-440-3 | FDA UDI | Class I | Active |
| Accufit | 3200-300 | FDA UDI | Class I | Active |
| Band Assemblies | 902-35108E-36.5 | FDA UDI | Class I | Active |
| Epic | 7E-L7R27-1 | FDA UDI | Class I | Active |
| Epic | 6E-U6L6-1 | FDA UDI | Class I | Active |
| Elite® Buccal Tubes Direct Bond | 951-252-10 | FDA UDI | Class I | Active |
| Stainless Steel Bright Pro Form™ Archwire | 100-151 | FDA UDI | Class I | Active |
| Aria® | 716-399MC-DSO | FDA UDI | Class I | Active |
Related Companies
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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. |