- Role
- Country
- Date of registration
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CZ-MF-000032589Dentapreg® SFU Refill is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by ADM, a.s.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Feb 4, 2026
85956527SFU9ZPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08595652700030
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
The use of Dentapreg® medical products is contraindicated in patients with known sensitivity to any of the components contained in Dentapreg® medical products (especially methacrylate monomers and polymers).
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Czechia; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | Apr 1, 2004 | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | Apr 1, 2004 | Still on market |
| Cyprus | — | Still on market |
| Germany | Apr 1, 2004 | Still on market |
| Denmark | Apr 1, 2004 | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | Apr 1, 2004 | Still on market |
| Finland | Apr 1, 2004 | Still on market |
| France | Apr 1, 2004 | Still on market |
| Croatia | — | Still on market |
| Hungary | Apr 1, 2004 | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | Apr 1, 2004 | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | Apr 1, 2004 | Still on market |
| Luxembourg | — | Still on market |
| Latvia | Apr 1, 2004 | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | Apr 1, 2004 | Still on market |
| Portugal | — | Still on market |
| Romania | Apr 1, 2004 | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | Apr 1, 2004 | Still on market |
| Türkiye | Apr 1, 2004 | Still on market |
| XI | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08595652700030Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
85956527SFU9ZD-001UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q010199CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER85956527SFU9ZOn the marketDentapreg® SFU Economy85956527SFU9ZOn the marketDentapreg® SFU Minirefill85956527SFU9ZOn the marketDentapreg® SFU Reinforcement85956527SFU9ZOn the marketDentapreg® SFU Sample85956527SFU9ZOn the marketDentapreg® SFU Sample Clin85956527SFU9ZOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
25 0302 QR/NBIssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
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