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Anthos

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 71R10000Model Dental Units

by Cefla Societa' Cooperativa

Identity

Trade Name
R7 ORTHO EUDAMED
Anthos FDA UDI
Generic Name
Dental delivery system FDA UDI
Device Name
The device is a dental unit consisting of components and/or devices that are functionally connected, such as the patient dental chair, dental unit, dental handpieces, multifunction pedal and operating light. This is a dental unit with ambidextrous hydric unit, in which the dental chair is placed on the floor, while the hydric unit is solidly attached to the chair and can be oriented to the right or to the left of the chair. This device is in "ORTHO" version: it is not provided with a dentist table, which is replaced by a tray; the instruments are on the assistant's board, which is mounted on a double-articulated tubular arm. The last four characters "XXXX" of the catalog number can be different alphanumeric characters. FDA UDI
Model / Reference
Dental Units EUDAMED
71R10000 EUDAMED
R7 ORTHO FDA UDI
Description
The device is a dental unit consisting of components and/or devices that are functionally connected, such as the patient dental chair, dental unit, dental handpieces, multifunction pedal and operating light. This is a dental unit with ambidextrous hydric unit, in which the dental chair is placed on the floor, while the hydric unit is solidly attached to the chair and can be oriented to the right or to the left of the chair. This device is in "ORTHO" version: it is not provided with a dentist table, which is replaced by a tray; the instruments are on the assistant's board, which is mounted on a double-articulated tubular arm. The last four characters "XXXX" of the catalog number can be different alphanumeric characters. FDA UDI

Identifiers

Catalog Number
71R1XXXX FDA UDI
Primary DI / UDI-DI
08033837933366 EUDAMEDFDA UDI
Basic UDI-DI
803383793TRDENTUNA001QY EUDAMED
Direct Marketing DI
08033837933366 EUDAMED
FDA Product Code
ELC FDA UDI
EIA FDA UDI
EMDN Code
Z12110101 DENTAL TREATMENT UNITS EUDAMED
GMDN Term
Dental delivery system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.4850 FDA UDI
872.6640 FDA UDI
Market of Registration
Italy EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental delivery system

Anthos by Cefla Societa' Cooperativa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental delivery system.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cefla Societa' Cooperativa

Sources (2)

  • FDA UDI 76efe0fc-0411-46d9-9835-97b3f9697d6f 36 fields · synced Jul 21, 2026
  • EUDAMED 269b6b68-07aa-4309-8ffa-52d3c1d0eaf6 61 fields · synced Jul 21, 2026