Identity
- Trade Name
- ORLUS MINI SCREW FDA UDI
- Generic Name
- Orthodontic anchoring screw FDA UDI
- Model / Reference
- 2O16107 FDA UDI
Identifiers
- Catalog Number
- 2O16107 FDA UDI
- Primary DI / UDI-DI
- 08809283891181 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Orthodontic anchoring screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.6 Millimeter FDA UDI
Category: Orthodontic anchoring screw
Orlus Mini Screw by Ortholution Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic anchoring screw.
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
- Absoanchor Microimplant — DENTOS Inc. · Class II
- Absoanchor Microimplant — DENTOS Inc. · Class II
- GBR System Bone Screw — Jeil Medical Corporation · Class II
- Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
- 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ortholution Co., Ltd.
Sources (1)
- FDA UDI 5ba0ab20-81fc-4951-a56d-fcbd419dac00 34 fields · synced May 30, 2026