Castellini 72CCXXXX, 72CDXXXX

GUDID 08033837933939

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.

CEFLA SOCIETA' COOPERATIVA

Dental delivery system
Primary Device ID08033837933939
NIH Device Record Key382e1a71-7043-48f0-96b7-6628db41a26c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCastellini
Version Model NumberDAMA AMBIDX
Catalog Number72CCXXXX, 72CDXXXX
Company DUNS429341410
Company NameCEFLA SOCIETA' COOPERATIVA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com
Phone+1 (704)598-0020
Emailservice@cefladental.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108033837933939 [Primary]

FDA Product Code

ELCScaler, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-16
Device Publish Date2021-11-08