Castellini

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 72CC0000, 72CD0000Model Dental Units

by Cefla Societa' Cooperativa

Identity

Trade Name: DAMA AMBIDX EUDAMED
Castellini 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 handpieces, multifunction pedal. In this version, the hydric unit and the dentist board are not present. The device consists of the single dental chair and, optionally, of the assistant's board with instruments connected to it. The patient dental chair can mount single-phase lifting motors (catalog number: 72CCXXXX) or three-phase lifting motors (catalog number: 72CDXXXX). The last four characters "XXXX" of the catalog number can be different alphanumeric characters. FDA UDI
Model / Reference: Dental Units EUDAMED
72CC0000, 72CD0000 EUDAMED
DAMA AMBIDX 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 handpieces, multifunction pedal. In this version, the hydric unit and the dentist board are not present. The device consists of the single dental chair and, optionally, of the assistant's board with instruments connected to it. The patient dental chair can mount single-phase lifting motors (catalog number: 72CCXXXX) or three-phase lifting motors (catalog number: 72CDXXXX). The last four characters "XXXX" of the catalog number can be different alphanumeric characters. FDA UDI

Identifiers

Catalog Number: 72CCXXXX, 72CDXXXX FDA UDI
Primary DI / UDI-DI: 08033837933939 EUDAMEDFDA UDI
Basic UDI-DI: 803383793TRDENTUNA001QY EUDAMED
Direct Marketing DI: 08033837933939 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

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental delivery system

Castellini 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.

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V8 TOUCH — VITALI S.R.L. · Class IIa
Forest — Ls Enterprises, Inc. · Class I
Forest — Ls Enterprises, Inc. · Class I
TY-830 — Foshan Toye Dental Equipment Co., Ltd · Class I
Forest — Ls Enterprises, Inc. · Class I
A5 SINGLE CART — CEFLA s.c. · Class IIa
Forest — Ls Enterprises, Inc. · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Cefla Societa' Cooperativa

Sources (3)

FDA UDI 382e1a71-7043-48f0-96b7-6628db41a26c 36 fields · synced Jul 10, 2026
EUDAMED 0748f469-1a3b-4807-96dc-e1848bf5af7e-1 61 fields · synced Jul 10, 2026
EUDAMED 0748f469-1a3b-4807-96dc-e1848bf5af7e-2 61 fields · synced Jul 10, 2026