# Maximat plus kit

> Withdrawn: No longer placed on the EU market. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/maximat-plus-kit-5190>
- Manufacturer: [Polydentia SA](https://devicerts.com/manufacturers/polydentia-sa) (Switzerland)
- Device class: Class I (EU MDR / US FDA)
- FDA product code: DZN
- EMDN: Q01010401 PAPER AND GUTTA-PERCHA TIPS, MATRICES AND WEDGES FOR DENTISTRY
- GMDN: Dental matrix band kit (62764)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI \+E29951900 · listed 2022-04-01 · status: Listed (GUDID: in commercial distribution)
- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI \++E299MPIVG · UDI-DI \+E29951900 · registered 2021-11-08 · status: Withdrawn (No longer placed on the EU market)

## Recalls

No recall on record.

## Identity

- Generic name: Dental matrix band kit [FDA GUDID (AccessGUDID)]
- Model / reference: 5190 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: \+E29951900 [EUDAMED]; E29951900 [FDA GUDID (AccessGUDID)]
- Basic UDI-DI: \++E299MPIVG [EUDAMED]
- FDA product code: DZN [FDA GUDID (AccessGUDID)]
- EMDN code: Q01010401 [EUDAMED]
- GMDN term: Dental matrix band kit (62764) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class I [EUDAMED, FDA GUDID (AccessGUDID)]
- Regulation number: 872.4565 [FDA GUDID (AccessGUDID)]
- System or procedure pack: Procedure pack [EUDAMED]
- EU registration type: System or procedure pack [EUDAMED]
- Medical purpose: Circumferential matrices for posterior dental restorations [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Clinical & Handling

- Sterilisation method: Moist Heat or Steam Sterilization [FDA GUDID (AccessGUDID)]

## Properties

- Sterilise before use: Yes [EUDAMED, FDA GUDID (AccessGUDID)]
- Premarket exempt: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Prescription use: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Maximat plus kit, Polydentia SA. deviCERTS medical device catalogue. https://devicerts.com/devices/maximat-plus-kit-5190 (data as of 2026-11-14).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/maximat-plus-kit-5190.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/maximat-plus-kit-5190
- 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.