EUDAMED last updated this device on Mar 30, 2026

REF 1954HTA3

++D058CCDISKZR2AGC

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: INTERDENT proizvodnja in trgovina, d.o.o.
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 →: +D058000001954HTA30
Reference / catalog number: REF 1954HTA3

REF 1954HTA3 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by INTERDENT proizvodnja in trgovina, d.o.o.. Placed on the EU market in Slovenia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

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EUDAMED last updated this device on Mar 30, 2026

REF 1954HTA3

++D058CCDISKZR2AGC

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: INTERDENT proizvodnja in trgovina, d.o.o.
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 →: +D058000001954HTA30
Reference / catalog number: REF 1954HTA3

View device family (Basic UDI)

Device identification

Trade name: not provided
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 →: +D058000001954HTA30
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 →: ++D058CCDISKZR2AGC
Reference / catalog number: REF 1954HTA3
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 →: HIBCC

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: CC DISK Zr HT A3, 18 mm
Additional information URL: https://interdent.si/f/docs/Download/Interdent-Navodilo-2469-CCDiscZrHTMultilayer-2021-03-25-V35.pdf
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

+D058000001954HTA30

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

By subscribing you accept the Privacy Policy.

EMDN nomenclature code(s)

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

Q010699MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW999
Contraindications: Using in case of bruxism, inadequate strength of tooth structure or insufficient space is not recommended. Usage is also not recommended in case of inadequate oral hygiene or inadequate coordination of masticatory movements. Prosthetic substitutes made out of discs must not be used in case of unsatisfactory preparation of teeth and in case of mistakes in prosthetic substitute.
CW999
Safety precaution: Powder is harmful to health. Use suction unit. At manual treatment use protective mask FFP1 and wear goggles.
CW999
Side effects: Consider possibility of allergic hypersensitivity to the powder.

Compliance flags

Safety

Reprocessed single-use

Direct marking

Substances

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Slovenia; available across 32 countries total.

Country	On market since	Until
SloveniaPrimary placement		Still on market
Austria		Still on market
Belgium		Still on market
Bulgaria		Still on market
Cyprus		Still on market
Czechia		Still on market
Germany		Still on market
Denmark		Still on market
Estonia		Still on market
EL		Still on market
Spain		Still on market
Finland		Still on market
France		Still on market
Croatia		Still on market
Hungary		Still on market
Ireland		Still on market
Iceland		Still on market
Italy		Still on market
Liechtenstein		Still on market
Lithuania		Still on market
Luxembourg		Still on market
Latvia		Still on market
Malta		Still on market
Netherlands		Still on market
Norway		Still on market
Poland		Still on market
Portugal		Still on market
Romania		Still on market
Sweden		Still on market
Slovakia		Still on market
Türkiye		Still on market
XI		Still on market

Device identification

Trade name: not provided
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 →: +D058000001954HTA30
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 →: ++D058CCDISKZR2AGC
Reference / catalog number: REF 1954HTA3
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 →: HIBCC

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: CC DISK Zr HT A3, 18 mm
Additional information URL: https://interdent.si/f/docs/Download/Interdent-Navodilo-2469-CCDiscZrHTMultilayer-2021-03-25-V35.pdf
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: INTERDENT proizvodnja in trgovina, d.o.o.
SRN: SI-MF-000004584
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

+D058000001954HTA30

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

By subscribing you accept the Privacy Policy.

EMDN nomenclature code(s)

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

Q010699MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW999
Contraindications: Using in case of bruxism, inadequate strength of tooth structure or insufficient space is not recommended. Usage is also not recommended in case of inadequate oral hygiene or inadequate coordination of masticatory movements. Prosthetic substitutes made out of discs must not be used in case of unsatisfactory preparation of teeth and in case of mistakes in prosthetic substitute.
CW999
Safety precaution: Powder is harmful to health. Use suction unit. At manual treatment use protective mask FFP1 and wear goggles.
CW999
Side effects: Consider possibility of allergic hypersensitivity to the powder.

Compliance flags

Safety

Reprocessed single-use

Direct marking

Substances

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

Certificates

No certificates registered for this manufacturer.

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

All products by INTERDENT proizvodnja in trgovina, d.o.o.

Market distribution

Primary placement in Slovenia; available across 32 countries total.

Country	On market since	Until
SloveniaPrimary placement		Still on market
Austria		Still on market
Belgium		Still on market
Bulgaria		Still on market
Cyprus		Still on market
Czechia		Still on market
Germany		Still on market
Denmark		Still on market
Estonia		Still on market
EL		Still on market
Spain		Still on market
Finland		Still on market
France		Still on market
Croatia		Still on market
Hungary		Still on market
Ireland		Still on market
Iceland		Still on market
Italy		Still on market
Liechtenstein		Still on market
Lithuania		Still on market
Luxembourg		Still on market
Latvia		Still on market
Malta		Still on market
Netherlands		Still on market
Norway		Still on market
Poland		Still on market
Portugal		Still on market
Romania		Still on market
Sweden		Still on market
Slovakia		Still on market
Türkiye		Still on market
XI		Still on market

REF 1954HTA3

REF 1954HTA3

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

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

Substances

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices