Castellini

FDA UDI

Class II (US FDA UDI)

by Cefla Societa' Cooperativa

Identity

Trade Name: 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 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. The last four characters "XXXX" of the catalog number can be different alphanumeric characters. FDA UDI
Model / Reference: PUMA ELI A R CP 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. The last four characters "XXXX" of the catalog number can be different alphanumeric characters. FDA UDI

Identifiers

Catalog Number: 71LBXXXX FDA UDI
Primary DI / UDI-DI: 08033837933878 FDA UDI
FDA Product Code: ELC FDA UDI
EIA FDA UDI
GMDN Term: Dental delivery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4850 FDA UDI
872.6640 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental delivery system.

Dental Unit — Lifedent (Zhuhai) Co., Ltd. · Class IIa
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 (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Cefla Societa' Cooperativa

Sources (1)

FDA UDI 503a2385-bd67-4efa-8e4b-28299b7b9162 36 fields · synced May 30, 2026