KöR 10-1008

GUDID 00850362007021

KöR Impression Tray Adhesive is an adhesive developed specifically for durable adhesion of addition curing vinyl silicone impression materials to disposable impression trays and avoids lifting of the impression material from the tray when taking the impression out of the mouth.

EVOLVE DENTAL TECHNOLOGIES, INC.

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• Primary Device ID: 00850362007021
• NIH Device Record Key: 6f9047b5-723a-4bc0-b3a4-50edc0fc360b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KöR
• Version Model Number: KöR Impression Tray Adhesive
• Catalog Number: 10-1008
• Company DUNS: 005479970
• Company Name: EVOLVE DENTAL TECHNOLOGIES, 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: false
• Device Combination Product: false
• Single Use: false
• 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: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com
• Phone: 949 713-0909
• Email: lfjastad@evolvedental.com

Device Dimensions

• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter
• Total Volume: 10 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850362007021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992001

FDA Product Code

• ELW: Material, Impression

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-25
• Device Publish Date: 2019-03-15

On-Brand Devices [KöR]

• 00850362007106: Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and
• 00850362007090: Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and
• 00850362007083: Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and
• 00850362007076: KöR Teeth Desensitizer - 5ml
• 00850362007069: KöR Teeth Desensitizer - 2.5ml
• 00850362007052: KöR Desensitizer-10ml
• 00850362007045: Impression Material - Super-Hydrophilic Vinyl Polysiloxane, Fast Set
• 00850362007038: Impression Material - Super-Hydrophilic Vinyl Polysiloxane Light Body Wash
• 00850362007021: KöR Impression Tray Adhesive is an adhesive developed specifically for durable adhesion of addi
• 00850362007014: Vinyl Polysiloxane Putty - Regular set impression material.
• 00850362007007: Vinyl Polysiloxane Putty - Fast set impression material.
• 00850362007175: Dental cheek retractor.
• 00850362007168: Dental cheek retractor.
• 00850362007151: Dental cheek retractor.
• 00850362007144: Dental Suction Tip
• 00850362007120: Dental retractor and suction tip.
• 00850362007113: Dental cheek retractor and suction tip.
• 00850362007137: Dental dam.