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Quadrant Core LC

by Cavex Holland BV

510(k) K984042

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 NumberK984042 Date4 Dec 1998ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 24 Sep 2026

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

Quadrant Core LC is a dental device. It was cleared by the FDA through the 510(k) process as substantially equivalent to a predicate device.

The device is manufactured by Cavex Holland BV and is classified under product code EBF. It was cleared on December 4, 1998, under k-number K984042.

From the manufacturer

Het Quadrant systeem van Cavex biedt voor iedere tandarts de juiste composiet vulling.

Source: cavex.nl

Similar devices

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