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EUDAMED last updated this device on Aug 31, 2023
B-06942053514322Dental Zirconia Block is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Shenzhen Yurucheng Dental Materials Co., Ltd.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0694205351432216187(01)06942053514322
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q010699MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER1 warning recorded — scroll inside the panel to see all entries.
In the event that there is an insufficient occlusal clearance and/or vertical prep wall, making the preparation unsuitable for an all-ceramic restoration, an alternative material must be chosen. Inlay bridges, endosseous implants and root posts are other contraindications.
CN-MF-000011505DD_2031977-1Primary placement in Türkiye; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| TürkiyePrimary placement | Jan 1, 2022 | Jun 14, 2023 |
| Italy | Jan 1, 2022 | Jun 14, 2023 |
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.
CN26/00000990IssuedNotified 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 →B-06942053529340On the marketDental Zirconia BlockB-06942053535310On the marketDental Zirconia BlockB-06942053535235On the marketDental Zirconia BlockB-06942053537031On the marketDental Zirconia BlockB-06942053534368On the marketDental Zirconia BlockB-06942053535730On the marketNo certificate specifically references this device's Basic UDI-DI.