EUDAMED last updated this device on Aug 13, 2026

TOTALCEM

B-03760260221115

On the marketClass IIa

Applicable legislation: —
Organization name: ITENA CLINICAL
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 →: 03760260221115
Reference / catalog number: TCEM3-VPTR

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

TOTALCEM is an EU-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by ITENA CLINICAL. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: TOTALCEM
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 →: 03760260221115
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 →: B-03760260221115
Reference / catalog number: TCEM3-VPTR
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 →: GS1

Classification

Risk category: Class IIa
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)03760260221115

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q0101010299TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

Do not use if package is damaged
Automix Tips are for single use only
OTHER
Uncured methacrrylate resin may cause contact dermatitis and damage the pulp. Avoid contact with skin, eyes and soft tissues wash thoroughly with water after contact
OTHER

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in France; available across 11 countries total.

Country	On market since	Until
FrancePrimary placement	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Italy	—	Still on market
Lithuania	—	Still on market
Poland	—	Still on market
Slovakia	—	Still on market

Related searches

Class IIa medical devices in EUDAMED

Device identification

Trade name: TOTALCEM
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 →: 03760260221115
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 →: B-03760260221115
Reference / catalog number: TCEM3-VPTR
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 →: GS1

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

Do not use if package is damaged
Automix Tips are for single use only
OTHER
Uncured methacrrylate resin may cause contact dermatitis and damage the pulp. Avoid contact with skin, eyes and soft tissues wash thoroughly with water after contact
OTHER

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

No certificates registered for this manufacturer.

Market distribution

Primary placement in France; available across 11 countries total.

Country	On market since	Until
FrancePrimary placement	—	Still on market
Belgium	—	Still on market
Bulgaria	—	Still on market
Czechia	—	Still on market
Germany	—	Still on market
EL	—	Still on market
Spain	—	Still on market
Italy	—	Still on market
Lithuania	—	Still on market
Poland	—	Still on market
Slovakia	—	Still on market

TOTALCEM

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Legacy certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates covering this device

Legacy certificates

Related devices

Certificates