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Bio Portadur Order-No.: 2017

by Wieland Edelmetalle GmbH & Co.

510(k) K012831

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012831 Date1 Nov 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EJT
Device Class
Class II
Regulation
21 CFR Part 872.3060
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Bio Portadur Order-No.: 2017 is a gold-based noble metal alloy designed for dental applications. Classified as a dental device, it is intended for use in restorative procedures, providing a durable and biocompatible material for dental restorations such as crowns, bridges, or inlays. This alloy is engineered to meet stringent dental standards, ensuring long-term performance and compatibility with oral tissues.

Supplied as a reusable dental material, the Bio Portadur Order-No.: 2017 is intended for use in clinical settings by dental professionals. It is regulated under FDA 510(k) clearance with a traditional review process, falling under device class II. The product adheres to regulatory requirements outlined in regulation number 872.3060 and is manufactured by Wieland Edelmetalle GmbH & Co. in Pforzheim, Germany. No specific sterility or MRI safety information is provided in the data.

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