- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jul 14, 2024
B-05901602121986Villacryl Opaker Kit 4x7gr powder (pink, brown, grey, yellow)+ 2x12ml liquid +12ml primer is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by EVERALL7 SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ. Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05901602121986V210Z10PL-MF-000018646PL19/1102977398(01)05901602121986
8 warnings recorded — scroll inside the panel to see all entries.
Contains Benzoyl Peroxide. May produce an allergic reaction.
Flam. Liq. 2
Contains Isopropyl alcohol
OTHER
OTHER
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 Poland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| PolandPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q010699MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHERPrimary 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 →590160212ITRNOn the marketVILLACRYL IT zgreen 21 g powder + 6 ml liquid590160212ITRNOn the marketVILLACRYL OPAKER 2x7 gr powder (pink )+12 ml liquid+12 ml primer590160212CROEHOn the marketVILLACRYL ORTHO 12 red color concentrate590160212ORTGPOn the marketVILLACRYL ORTHO 500g powder+250ml liquid +3x12 color concentrates590160212ORTGPOn the marketVILLACRYL ORTHO color concentrate 50ml blue590160212ORTGPOn the marketNo certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.