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PEEK Biosolution

by Merz Dental GmbH

510(k) K173124

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 NumberK173124 Date18 Dec 2017ClearedStatusActive

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  • Withdrawn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
EBF
Device class
Class II
Regulation
21 CFR Part 872.3690
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

PEEK Biosolution is a PolyEtherEtherKeton material used for definitive fixed constructions such as bridge frameworks and subgingivally placed hybrid abutments and cervical gingivaformers. It combines biocompatibility with high load-bearing capacity for the biological balance between prosthesis bed and restorative material.

The device is supplied as a 95mm rod and is manufactured through an industrially controlled process with consistently high quality. It has extremely high flexural strength and wear resistance due to a controlled industrial technical long-term temper process that guarantees minimal material tension and homogeneous crystallisation. The device has FDA 510(k) clearance with product code EBF.

Other devices from Merz Dental GmbH

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Questions

AI-generated answers, 6 Oct 2026

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

  • What is PEEK Biosolution used for in dental applications?

    PEEK Biosolution is a PolyEtherEtherKeton material used for definitive fixed dental constructions such as bridge frameworks and subgingivally placed hybrid abutments and cervical gingivaformers, combining biocompatibility with high load-bearing capacity.

  • How is PEEK Biosolution supplied and what are its key properties?

    The device is supplied as a 95mm rod and features extremely high flexural strength and wear resistance due to a controlled industrial technical long-term temper process that guarantees minimal material tension and homogeneous crystallisation.

  • What is the regulatory status of PEEK Biosolution?

    PEEK Biosolution has FDA 510(k) clearance with product code EBF, received on December 18, 2017, with the decision code SESE indicating it is substantially equivalent to other devices on the market.

  • Is PEEK Biosolution suitable for single-use or multiple applications?

    The device description does not specify whether PEEK Biosolution is intended for single-use or multiple applications, as this information is not provided in the device data.