Absoanchor Microimplant
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by DENTOS Inc.
Identifiers
- 510(k) Number
- K181142 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 Absoanchor Microimplant is an endosseous orthodontic implant, designed for skeletal anchorage in orthodontic treatment. It is a small, self-drilling device inserted into the alveolar bone to provide stable fixation points for tooth movement, eliminating the need for patient cooperation with traditional appliances.
Supplied as a single-use, sterile device, the Absoanchor Microimplant is intended for use in dental clinics under aseptic conditions. It is classified as a Class II medical device under FDA regulations (21 CFR 872.3640) and has received FDA 510(k) clearance and MDR authorization. Available in various sizes and configurations, it is engineered for precise orthodontic applications and must be handled with sterile instruments to maintain integrity.
Frequently asked questions
What is the Absoanchor Microimplant used for in orthodontic treatment?
The Absoanchor Microimplant is designed specifically for skeletal anchorage in orthodontics. It provides stable fixation points within the alveolar bone to facilitate precise tooth movement without relying on patient cooperation with traditional appliances, such as headgear or retainers.
Is the Absoanchor Microimplant intended for single-use or can it be reused?
The Absoanchor Microimplant is supplied as a single-use device. This ensures sterility and integrity, as it must be handled under aseptic conditions in dental clinics, preventing cross-contamination or compromise of its structural reliability.
How is the Absoanchor Microimplant supplied, and what does this mean for handling?
It is supplied sterile and ready for immediate use, meaning it comes pre-packaged to maintain sterility until deployment. Clinicians must use sterile instruments when handling it to preserve its sterile state and prevent contamination, as it is not designed for reuse.
Are there different sizes or configurations available for the Absoanchor Microimplant?
Yes, the Absoanchor Microimplant is available in various sizes and configurations, allowing clinicians to select the appropriate implant for specific orthodontic applications and patient anatomy. This versatility supports tailored treatment planning.
What regulatory pathways has the Absoanchor Microimplant undergone, and what does this imply for its use?
The device has received FDA 510(k) clearance and MDR authorization, confirming it meets regulatory standards for Class II medical devices under FDA regulations (21 CFR 872.3640). This implies it has been evaluated for safety and effectiveness in its intended orthodontic use and can be legally marketed and used in the U.S. and EU.
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
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181142 | Class II | Active |
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Manufacturer
- Manufacturer
- DENTOS Inc.
- FDA Applicant
- Dentos, Inc.
Sources (2)
- FDA 510(k) K181142 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026