ROEKO Calcium Hydroxide PLUS Points 366840

GUDID E1653668401

Coltène/Whaledent GmbH + Co. KG

Root canal obturating point

• Primary Device ID: E1653668401
• NIH Device Record Key: df8dfcad-c916-42aa-915b-62044be43755
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROEKO Calcium Hydroxide PLUS Points
• Version Model Number: ISO 40
• Catalog Number: 366840
• Company DUNS: 315494443
• Company Name: Coltène/Whaledent GmbH + Co. KG
• Device Count: 60
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com
• Phone: +4973458050
• Email: info.de@coltene.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *keep dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E1653668400 [Unit of Use]
HIBCC	E1653668401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973539

FDA Product Code

• EJK: Liner, Cavity, Calcium Hydroxide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-12-17
• Device Publish Date: 2018-02-01

On-Brand Devices [ROEKO Calcium Hydroxide PLUS Points]

• E16555330: SAMPLE
• E1653668970: ASSORTMENT ISO 45-80
• E1653668960: ASSORTMENT ISO 15-40
• E1653668801: ISO 80
• E1653668701: ISO 70
• E1653668601: ISO 60
• E1653668551: ISO 55
• E1653668501: ISO 50
• E1653668451: ISO 45
• E1653668401: ISO 40
• E1653668351: ISO 35
• E1653668301: ISO 30
• E1653668251: ISO 25
• E1653668201: ISO 20
• E1653668151: ISO 15