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MARK3

by Cavex Holland BV

510(k) K141092

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK141092 Date4 Dec 2014ClearedStatusActive

Official records

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  • Withdrawn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
ELW
Device class
Class II
Regulation
21 CFR Part 872.3660
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

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

The Mark3 is a dental impression material designed for capturing precise oral impressions. Classified as a Class II medical device, it is used primarily in dentistry to create accurate moulds of teeth and surrounding structures for further prosthetic or orthodontic procedures.

This material is supplied in sterile, single-use packaging and is intended for use in clinical settings by dental professionals. It is non-magnetic and compatible with MRI environments. The device is authorised under FDA 510(k) clearance (K141092) and adheres to regulatory standards outlined in 21 CFR 872.3660. Multiple registration numbers and FEI numbers are associated with its various formulations, ensuring traceability and compliance.

Similar devices

Other devices filed under FDA product code ELW (Material, Impression).

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