- Role
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IT-MF-00002766327357Calcinable Caps for Angled and Monoblocco Abut. for Screwed-in Prosthesis + no. 2 Secondary Connection Screws is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Edierre Implant System Srl. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 21, 2026
B-08055728022560Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08055728022560
1 warning recorded — scroll inside the panel to see all entries.
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 Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Apr 6, 2005 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
08055728022560Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-08055728022560P430000UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Q010280PROSTHETIC DENTISTRY DEVICES - ACCESSORIESNo 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.B-08055728021914On the marketCALCINABLE ABUTMENT + connection screwB-08055728021891On the marketCALCINABLE ABUTMENT + connection screwB-08055728021907On the marketCALCINABLE CAPS FOR STRAIGHT ABUTMENT FOR SCREWED IN PROSTHESIS + two secondary connection screwsB-08055728023451On the marketCALCINABLE CAPS FOR STRAIGHT ABUTMENT FOR SCREWED IN PROSTHESIS + two secondary connection screwsB-08055728023444On the marketCALIBRATED CONICAL DRILL W/IRRIGATION FOR PRIMER SHORT IMPLANTB-08055728023086On the market