Identifiers
- 510(k) Number
- K232560 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
An angled abutment is a dental device intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or over-dentures. It is designed to interface between the implant and the prosthetic component to facilitate proper alignment and retention of the restoration.
The device is supplied as a non-sterile, reusable component intended for use in dental clinical settings. It has received FDA 510(k) clearance under K232560, is classified as a Class II device with product code NHA, and was cleared via the traditional pathway following a 118-day review. No information regarding sterility, single-use status, MRI safety, specific sizes, or storage conditions is provided in the data.
Frequently asked questions
What is an angled abutment used for in dental procedures?
An angled abutment is a dental device designed to interface between a dental implant and prosthetic restorations such as crowns, bridges, or over-dentures. It provides support and facilitates proper alignment and retention of the restoration.
Is the angled abutment supplied as a sterile or single-use device?
The angled abutment is supplied as a non-sterile, reusable component intended for use in dental clinical settings. No information regarding sterility or single-use status is provided in the device data.
What regulatory approvals has the angled abutment received?
The angled abutment has received FDA 510(k) clearance under K232560. It is classified as a Class II device with product code NHA and was cleared via the traditional pathway following an 118-day review.
Are there different sizes or models of the angled abutment available?
No information regarding specific sizes or models of the angled abutment is provided in the device data. The description only indicates it is designed for use with dental implants to support various prosthetic restorations.
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: Angled Abutment by Arum Dentistry Co., Ltd. | FDA 510(k) Summary, K232560 FDA 510(k) - Angled Abutment | Arum Dentistry Co., Ltd., ARUM DENTISTRY- the premium Dental CAD/CAM milling machine, PDF Daejeon, 34002 Re: K232560 Trade/Device Name: Angled Abutment ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232560 | Class II | Active |
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Manufacturer
- Manufacturer
- ARUM DENTISTRY Co., Ltd.
Sources (1)
- FDA 510(k) K232560 24 fields · synced Sep 24, 2026