KöR 10-1015

GUDID 00850362007038

Impression Material - Super-Hydrophilic Vinyl Polysiloxane Light Body Wash

EVOLVE DENTAL TECHNOLOGIES, INC.

Silicone dental impression material

• Primary Device ID: 00850362007038
• NIH Device Record Key: e52cbcfa-d279-4f86-85b2-b98e88337952
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KöR
• Version Model Number: KöR Light Body Wash
• Catalog Number: 10-1015
• 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 7130909
• Email: lfjastad@evolvedental.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Maximum Storage Temperature 73°F (23°C)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850362007038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041028

FDA Product Code

• ELW: Material, Impression

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: 2018-07-06
• Device Publish Date: 2017-03-10

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.