TE-95 BC Turbine

GUDID J021100595090

Alegra Highspeed Handpiece

W & H Dentalwerk Bürmoos GmbH

Dental power tool system handpiece, pneumatic

Primary Device ID	J021100595090
NIH Device Record Key	55175650-8c5d-4289-868e-b689888c7054
Commercial Distribution Discontinuation	2019-06-05
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	TE-95 BC Turbine
Version Model Number	10059509
Company DUNS	300238441
Company Name	W & H Dentalwerk Bürmoos GmbH
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

Operating and Storage Conditions

Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Humidity	Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Humidity	Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Humidity	Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Humidity	Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Humidity	Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Humidity	Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Humidity	Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Humidity	Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Humidity	Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Humidity	Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Humidity	Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Humidity	Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 35 Degrees Celsius
Handling Environment Humidity	Between 15 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Humidity	Between 8 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment Temperature	Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J02110059509 [Primary]
HIBCC	J021100595090 [Direct Marking]
HIBCC	J021100595091 [Primary]

FDA Product Code

EFB	Handpiece, Air-Powered, Dental