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Pro-Crylic Resin, Technicolor Pre-Mix Monomer

by Professional Positioners, Inc.

510(k) K943905

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 NumberK943905 Date27 Feb 1995ClearedStatusActive

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  • Withdrawn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
EBI
Device Class
Class II
Regulation
21 CFR Part 872.3760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Pro-Crylic Resin, Technicolor Pre-Mix Monomer is a dental device used in clinical applications. It functions as a resin and monomer solution for dental procedures.

This device is identified by K-number K943905 and has received FDA 510(k) clearance. It is manufactured by Professional Positioners, Inc. and is classified under product code EBI.

Other devices from Professional Positioners, Inc.

Questions

AI-generated answers, 23 Sep 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 the Pro-Crylic Resin Technicolor Pre-Mix Monomer used for?

    This device is a dental resin and monomer solution intended for use in clinical dental procedures as specified by the manufacturer, Professional Positioners, Inc.

  • What is the regulatory status of this dental resin?

    The Pro-Crylic Resin Technicolor Pre-Mix Monomer has received FDA 510(k) clearance under K-number K943905, indicating it has been found substantially equivalent to legally marketed predicate devices.

  • How is this device classified for regulatory purposes?

    The device is classified under product code EBI, which falls under the oversight of the Dental advisory committee.