# MK-dent ACCESSORIES

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/mk-dent-qc5016sw>
- Manufacturer: [MK-Dent GmbH](https://devicerts.com/manufacturers/mk-dent-gmbh) (Germany)
- Device class: Class IIa (EU MDD); Class I (US FDA)
- FDA product code: EFB
- EMDN: Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER
- GMDN: Pneumatic dental handpiece coupler (45121)

## Registrations and authorizations

- **EUDAMED** · CE/MDD · European Union · Basic UDI-DI B-+E490QC5016SW17 · UDI-DI \+E490QC5016SW17 · registered 2026-10-05 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI \+E490QC5016SW17 · listed 2024-10-14 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K032234 · decision 2003-10-02 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: Coupling [EUDAMED]; MK-dent [FDA GUDID (AccessGUDID)]
- Generic name: Pneumatic dental handpiece coupler [FDA GUDID (AccessGUDID)]
- Device name: Quick Connector, 4 holes (6 pins) [EUDAMED]
- Model / Ref / Catalog: QC5016SW [EUDAMED, FDA GUDID (AccessGUDID)]; ACCESSORIES [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: \+E490QC5016SW17 [EUDAMED]; E490QC5016SW1 [FDA GUDID (AccessGUDID)]
- Basic UDI-DI: B-+E490QC5016SW17 [EUDAMED]
- 510(k) Number: K032234 [FDA GUDID (AccessGUDID)]
- FDA product code: EFB [FDA GUDID (AccessGUDID)]
- EMDN code: Q010199 [EUDAMED]
- GMDN term: Pneumatic dental handpiece coupler (45121) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIa [EUDAMED]; Class I [FDA GUDID (AccessGUDID)]
- Regulation number: 872.4200 [FDA GUDID (AccessGUDID)]
- EU registration type: Legacy device (under a directive) [EUDAMED]
- EU market of registration: Germany [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Over-the-counter: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: MK-dent ACCESSORIES, MK-Dent GmbH. deviCERTS medical device catalogue. https://devicerts.com/devices/mk-dent-qc5016sw (data as of 2026-11-14).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/mk-dent-qc5016sw.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/mk-dent-qc5016sw
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.