Identifiers
- 510(k) Number
- K984042 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Frequently asked questions
What is the Quadrant Core LC used for?
The Quadrant Core LC is a dental device, as stated in its description, indicating its use in dental procedures, though specific clinical indications are not detailed in the provided data.
Who manufactures the Quadrant Core LC and where are they located?
The Quadrant Core LC is manufactured by Cavex Holland BV, located at 2003 Rw Haarlem, P.O. Box 852, Harmen, NL, with postal code 19-21, as provided in the device specifications.
How was the Quadrant Core LC cleared for market release?
The Quadrant Core LC was cleared by the FDA through the traditional 510(k) process on December 4, 1998, under k-number K984042, as substantially equivalent to a predicate device, based on the decision description and clearance type in the data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: QUADRANT CORE LC — K984042 · DeviceClearance, QUADRANT CORE LC (K984042) — FDA 510 (k) | Innolitics, PDF K984042 - Quadrant Core Lc, Quadrant Archives - Cavex
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K984042 | Class II | Active |
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Manufacturer
- Manufacturer
- Cavex Holland BV
Sources (1)
- FDA 510(k) K984042 24 fields · synced Sep 24, 2026