Gutta Easy

GUDID 08800017900063

The Gutta Easy is the highly efficient gutta percha back fill obturation device. With its distinctive and inimitable features, the Gutta Easy makes thermo-plasticized root canal obturation much easier and faster than ever. The Gutta Easy's powerful and rapid heating control mechanisms delivers reliable and optimum clinical results.

DXM CO., LTD

Root canal obturation kit

Primary Device ID	08800017900063
NIH Device Record Key	c613f6c3-eca0-4345-8571-a55be95b9951
Commercial Distribution Status	In Commercial Distribution
Brand Name	Gutta Easy
Version Model Number	Gutta Easy
Company DUNS	688797315
Company Name	DXM CO., LTD
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	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

Operating and Storage Conditions

Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 60 KiloPascal and 106 KiloPascal
Handling Environment Humidity	Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800017900063 [Primary]

FDA Product Code

EKR	Plugger, Root Canal, Endodontic