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Calcinabili

EUDAMEDFDA UDI

Class I (EU MDR)

Ref GC

by Rhein 83 S.r.l.

Identity

Trade Name
OT EQUATOR FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
Calcinabili EUDAMED
Set of devices intended to be incorporated into a dental prosthesis and fix it onto OT Equators attachments already present into the patient's mouth. FDA UDI
Model / Reference
GC EUDAMED
CASTABLE SLEEVE for Tit. Abutm. 1 pcs. FDA UDI
Description
Set of devices intended to be incorporated into a dental prosthesis and fix it onto OT Equators attachments already present into the patient's mouth. FDA UDI

Identifiers

Catalog Number
GC FDA UDI
Primary DI / UDI-DI
08059224168173 EUDAMEDFDA UDI
Basic UDI-DI
805804571CLCK5 EUDAMED
FDA Product Code
EJX FDA UDI
EMDN Code
Q010299 PROSTHETIC DENTISTRY DEVICES - OTHER EUDAMED
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
872.3130 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Calcinabili by Rhein 83 S.r.l. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rhein 83 S.r.l.
EUDAMED SRN
IT-MF-000005998

Sources (2)

  • EUDAMED e7458bcb-9105-4a85-99be-f8f6c4c099c5 61 fields · synced Jul 21, 2026
  • FDA UDI 040b8783-9f7e-4186-8dfb-d4e417ede83f 34 fields · synced May 30, 2026