Sl Type Orthodontic Anchor Screws, Spl Type Orthodontic Anchor Screws
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K111809 FDA 510(k)
- FDA Product Code
- OAT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SL Type and SPL Type Orthodontic Anchor Screws are endosseous implants designed for orthodontic anchorage. These devices are inserted into bone to provide stable fixation points for orthodontic appliances, aiding in tooth movement and alignment during treatment.
These screws are supplied as single-use, sterile devices intended for dental professional use. They are classified as Class II medical devices under FDA regulations (21 CFR 872.3640) and have received FDA 510(k) clearance and MDD authorization. Various sizes and reference codes are available, as listed in the registration records, and must be stored according to manufacturer instructions to maintain sterility.
Frequently asked questions
Are these orthodontic anchor screws designed for reuse or are they intended as single-use devices?
These SL Type and SPL Type Orthodontic Anchor Screws are explicitly supplied as single-use, sterile devices. The manufacturer’s instructions emphasize maintaining sterility, which aligns with their intended use in clinical settings where each screw is inserted once per patient to avoid contamination risks.
What storage conditions must be followed to preserve sterility for these screws?
The manufacturer requires adherence to their specific storage instructions to maintain sterility. While the exact conditions aren’t detailed here, typical orthodontic implants like these are generally stored in a dry, sealed environment (e.g., sterile packaging) away from direct light or extreme temperatures until use. Always follow the packaging labels or accompanying documentation for precise guidance.
How many different sizes or models are available for these orthodontic anchor screws?
Multiple sizes and reference codes are available, as indicated by the 15+ FEI numbers (e.g., 3009732568, 3011302692) and registration numbers listed in the records. These correspond to distinct screw dimensions tailored for various clinical applications. The exact measurements or model-specific details would require cross-referencing the manufacturer’s catalog or technical documentation.
What regulatory pathways have these orthodontic anchor screws undergone, and how does that affect their use?
The screws have received FDA 510(k) clearance (K111809) under the Special 510(k) pathway and MDD authorization, classifying them as Class II devices (21 CFR 872.3640). This means they’ve been evaluated for substantial equivalence to a predicate device and meet EU and U.S. safety/performance standards. Clinicians can rely on this regulatory history to confirm their compliance with dental implant standards.
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.
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 | K111809 | Class II | Active |
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Manufacturer
- Manufacturer
- BioMaterials Korea, Inc.
Sources (2)
- FDA 510(k) K111809 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026