Orthodontic Fixation Screw [Smart Anchor Miniscrew]
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by GNI Co., Ltd
Identity
- Trade Name
- Orthodontic Fixation Screw EUDAMEDSA2010 FDA UDI
- Generic Name
- Orthodontic anchoring screw FDA UDI
- Device Name
- Orthodontic Fixation Screw EUDAMED
- Model / Reference
- SA2010 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800046000635 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800046000635 EUDAMED
- 510(k) Number
- K191041 FDA 510(k)
- FDA Product Code
- OAT FDA 510(k)FDA UDI
- EMDN Code
- P010299 ODONTOLOGICAL PROSTHESES - OTHER EUDAMED
- GMDN Term
- Orthodontic anchoring screw FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)FDA UDI
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The Smart Anchor Miniscrew Orthodontic Fixation Screw is an endosseous dental implant designed for temporary anchorage in orthodontic treatment. It provides a stable fixation point for orthodontic appliances, including wires, springs, and elastic ligatures, to facilitate tooth movement in patients aged 12 and older.
This device is surgically placed in the upper or lower jaw bone by qualified dentists and is intended for single-use. It is classified under FDA Product Code OAT and has received FDA 510(k) clearance (K191041) and MDD authorization. The device is supplied sterile and adheres to regulatory standards for dental implants.
Frequently asked questions
What is the Smart Anchor Miniscrew used for in orthodontic treatment and who can use it?
The Smart Anchor Miniscrew is an endosseous dental implant designed to provide a stable fixation point for orthodontic appliances like wires, springs, and elastic ligatures. It helps facilitate controlled tooth movement during orthodontic treatment. This device is intended for patients aged 12 and older and is surgically placed in the upper or lower jaw bone by qualified dentists.
Is the Smart Anchor Miniscrew intended for single-use or can it be reused?
The Smart Anchor Miniscrew is explicitly designed for single-use only. After placement and use in orthodontic treatment, it is not meant to be removed and reused for another patient.
How is the Smart Anchor Miniscrew supplied, and is it sterile?
The Smart Anchor Miniscrew is supplied sterile, adhering to regulatory standards for dental implants. This ensures it is ready for immediate surgical placement without additional sterilization steps.
What regulatory pathways has the Smart Anchor Miniscrew followed, and what does that mean for its use?
The Smart Anchor Miniscrew has received FDA 510(k) clearance under the Traditional pathway (K191041) and MDD authorization. This means it has been evaluated and deemed substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed and used in the U.S. and EU for its intended orthodontic anchorage purpose.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Orthodontic Fixation Screw [Smart Anchor Miniscrew], PDF August 28, 2020 - Food and Drug Administration, K191041 - Orthodontic Fixation Screw [Smart Ancho... | FDA 510(k), Orthodontic Fixation Screw (UDI: 08800046000635) Specs & FDA Data
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K191041 | Class II | Active |
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Manufacturer
- Manufacturer
- GNI Co., Ltd
- FDA Applicant
- Gni Co., Ltd.
Sources (3)
- FDA 510(k) K191041 24 fields · synced Sep 18, 2026
- FDA UDI dfd5edf0-cc2e-40ef-8ddd-1d608ae2eada 32 fields · synced May 30, 2026
- EUDAMED 42c09fdb-1319-4d83-986a-90ee905540e3 61 fields · synced Jul 22, 2026