Identity
- Trade Name
- Expansion Screw FDA UDI
- Generic Name
- Orthodontic anchoring screw FDA UDI
- Device Name
- Vertical Arm Expansion Screw 9mm FDA UDI
- Model / Reference
- 4109-395 FDA UDI
- Description
- Vertical Arm Expansion Screw 9mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190707089894 FDA UDI
- FDA Product Code
- DYJ FDA UDI
- GMDN Term
- Orthodontic anchoring screw FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic anchoring screw
Expansion Screw by Ortho Organizers, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic anchoring screw.
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- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ortho Organizers, Inc.
Sources (1)
- FDA UDI 1f9b0958-6297-4e16-b3d4-a728cf378b6f 33 fields · synced Jun 9, 2026