Stern Weber 95520454

GUDID 08033837930723

The CEFLA Dental Micromotors are brushless electric micromotors controlled by a control unit inside CEFLA Dental Units. They are intended to be connected with an ISO-type handpiece attachment: straight or contra-angle of equal, gear-reducing, or gear increasing speed. They are intended for professional use in dental surgery such as: preventive dentistry, restorative applications, endodontic treatment, prosthetic applications and implantology practices.

CEFLA SOCIETA' COOPERATIVA

Dental power tool system handpiece, line-powered

Primary Device ID	08033837930723
NIH Device Record Key	d8cda756-fe6f-49fe-b788-b137571fec68
Commercial Distribution Status	In Commercial Distribution
Brand Name	Stern Weber
Version Model Number	i-XR3
Catalog Number	95520454
Company DUNS	429341410
Company Name	CEFLA SOCIETA' COOPERATIVA
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Operating and Storage Conditions

Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033837930723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K213022

FDA Product Code

EBW	Controller, Foot, Handpiece And Cord