Identifiers
- 510(k) Number
- K110275 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 Ortho Easy Pin is an endosseous orthodontic implant designed for skeletal anchorage in orthodontic treatment. It is made of biocompatible titanium and is intended to be inserted minimally invasively into the palate, the buccal region of the jaw, or interradicularly to provide a stable anchor for orthodontic appliances.
The device is classified as a Class II medical device and received traditional FDA 510(k) clearance (K110275) as a substantially equivalent implant. It is supplied by Forestadent Bernhard Förster GmbH and is listed under product code OAT. The pin is intended for single‑use clinical application in dental settings, with no specific MRI safety or sterility details provided in the available data.
Frequently asked questions
What is the Ortho Easy Pin used for in orthodontic treatment?
The Ortho Easy Pin is an endosseous orthodontic implant designed for skeletal anchorage. It provides a stable anchor point for orthodontic appliances when inserted minimally invasively into the palate, buccal region of the jaw, or interradicularly.
Is the Ortho Easy Pin reusable or single-use?
The Ortho Easy Pin is intended for single-use clinical application in dental settings. After insertion, it should not be reused on different patients or in different procedures to ensure patient safety and device integrity.
What is the Ortho Easy Pin made of and how is it supplied?
The Ortho Easy Pin is made of biocompatible titanium. It is supplied by Forestadent Bernhard Förster GmbH, though specific details about packaging, sterility, or MRI safety are not provided in the available data.
What is the regulatory classification of the Ortho Easy Pin?
The Ortho Easy Pin is classified as a Class II medical device and received traditional FDA 510(k) clearance (K110275) as a substantially equivalent implant. It is listed under product code OAT and is intended for dental applications.
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: OrthoEasy® - skeletal anchorage - FORESTADENT, OrthoEasy - Skelettale Verankerung - FORESTADENT, OrthoEasy® Pin and Pal Specifications | PDF | Mechanical ... - Scribd, Forestadent Bernhard Förster GmbH 1101A2308 OrthoEasy - RevMed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110275 | Class II | Active |
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Manufacturer
- Manufacturer
- Forestadent Bernhard Förster GmbH
- FDA Applicant
- Forestadent Bernhard Forster GmbH
Sources (1)
- FDA 510(k) K110275 24 fields · synced Oct 6, 2026