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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 2 of 248| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Elite Opti-MIM | 702-260-10 | FDA UDI | Class I | Active |
| O-Ties | 400-793 | FDA UDI | Class I | Active |
| Masel | 3904-014A | FDA UDI | Class II | Active |
| Carriere SLX | 713-390HK-10 | FDA UDI | Class I | Active |
| Maestro | 711-399SBI | FDA UDI | Class I | Active |
| Maestro | 711-287HK-10 | FDA UDI | Class I | Active |
| Band Assemblies | 900-124082E-34.5 | FDA UDI | Class I | Active |
| Epic | 7E-L7L34-1 | FDA UDI | Class I | Active |
| Masel | 4828-1127 | FDA UDI | Class I | Active |
| Safe-T-Ties™ | 400-427 | FDA UDI | Class I | Active |
| Elite Opti-MIM | 702-250HK-10 | FDA UDI | Class I | Active |
| Elite | 900-1718-385-3 | FDA UDI | Class I | Active |
| Silhouette | 2886-375-5 | FDA UDI | Class I | Unknown |
| Elite® | 902-048-10 | FDA UDI | Class I | Active |
| Silhouette | 2886-421-5 | FDA UDI | Class I | Unknown |
| NeoCrystal Plus | 715-272HK-5 | FDA UDI | Class II | Active |
| Aria | 716-155-10 | FDA UDI | Class I | Active |
| Illusion Plus International | 708-255-10 | FDA UDI | Class I | Active |
| Maestro® Band Assemblies | 911-361091E-40.5 | FDA UDI | Class I | Active |
| Maestro® | 902-301DB-10 | FDA UDI | Class I | Active |
| Ortho Organizers | 033-092 | FDA UDI | Class I | Active |
| Elite | 900-11581-380-3 | FDA UDI | Class I | Active |
| Epic | 7E-L7R19-1 | FDA UDI | Class I | Active |
| Masel | 5011-404 | FDA UDI | Class I | Active |
| ClassOne | 104-40 | FDA UDI | Class I | Active |
| Mini Unicycle™ | 4120-863 | FDA UDI | Class I | Active |
| Elite® Band Assemblies | 900-14408E-3 | FDA UDI | Class I | Active |
| Band Assemblies | 902-142086E-41 | FDA UDI | Class I | Active |
| Band Assemblies | 068 | FDA UDI | Class I | Active |
| Variable Force 3™ Thermal Nitanium® Archwire | 104-973 | FDA UDI | Class I | Active |
| Carriere SLX | 713-372HK-10 | FDA UDI | Class I | Active |
| Elite® Band Assemblies | 900-11408E-3 | FDA UDI | Class I | Active |
| Elite® Mini-Twin® Vertical Slot | 706-857-10 | FDA UDI | Class I | Unknown |
| Elite Opti-MIM | 702-308-10 | FDA UDI | Class I | Active |
| Band Assemblies | 900-109081E-38 | FDA UDI | Class I | Active |
| Elite | 900-01581-325-3 | FDA UDI | Class I | Active |
| Maestro | 711-357-10 | FDA UDI | Class I | Active |
| Masel | 3904-033A | FDA UDI | Class II | Active |
| Prophy Paste | 504-90 | FDA UDI | Class I | Unknown |
| Envision | 701-088-5 | FDA UDI | Class II | Active |
| Band Assemblies | 900-107061E-9 | FDA UDI | Class I | Active |
| Elite® Band Assemblies | 900-11207E-3 | FDA UDI | Class I | Active |
| Stainless Steel Archwires | 101-405 | FDA UDI | Class I | Active |
| SLX™ Clear Aligners | 128-AL58 | FDA UDI | Class II | Active |
| Bio-Kinetix® Thermal Nitanium®archwires | 100-850 | FDA UDI | Class I | Active |
| Masel | 5011-603 | FDA UDI | Class I | Active |
| Carriere® SLX 3D™ | 776-KIT-HK | FDA UDI | Class II | Active |
| Carriere® SLX™ | 713-251HK-10-OP | FDA UDI | Class I | Active |
| Elite | 900-02181-325-3 | FDA UDI | Class I | Active |
| Elite® Band Assemblies | 900-124081E-41.5 | 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. |