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EUDAMED last updated this device on May 21, 2026
B-08806387860020R&S Temporary Cement is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by META BIOMED CO., LTD.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08806387860020-(01)08806387860020
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q0101010203TEMPORARY DENTAL CEMENTS1 warning recorded — scroll inside the panel to see all entries.
• Do not use this product on a patient with a history of hypersensitiveness such as rashes or dermatitis. • Stop using the product if symptoms of hypersensitiveness such as a rash or dermatitis appear. • The product is only for oral tissues so take care to keep the product away from the eyes. • If eyes or skin are exposed to un-polymerized product, cleanse with plenty of water and consult a doctor. • This product is intended only for its primary purpose and should not be used for any other purpose. • Remove residual cement from the sulcus or the proximal. • Use equal quantity base and Catalyst pastes.
KR-MF-000009681KR19/81826259Primary placement in Germany; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jan 31, 2007 | Still on market |
| France | Jan 31, 2007 | Still on market |
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.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Certificate health across this manufacturer's portfolio.
M.2025.MDR.1058AmendedHZ 2020208-1AmendedM.2025.MDR.1058-1WithdrawnNotified 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.
View in glossary →Notified 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.
View in glossary →Notified 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.
View in glossary →No certificate specifically references this device's Basic UDI-DI.