StarDental Instrument Solutions

GUDID D7022688800

ETORQUE EDUCATION KIT

DENTALEZ, INC.

Dental power tool system handpiece, line-powered

Primary Device ID	D7022688800
NIH Device Record Key	c7680b45-dad1-4de4-a262-32f6719cf0ae
Commercial Distribution Status	In Commercial Distribution
Brand Name	StarDental Instrument Solutions
Version Model Number	268880
Company DUNS	059010363
Company Name	DENTALEZ, INC.
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	true
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	false
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	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx
Phone	1-866-383-4636
Email	xx@xx.xx

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7022688800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K090937

FDA Product Code

EBW	Controller, Foot, Handpiece And Cord