KöR 80-1032

GUDID 00850362007137

Dental dam.

EVOLVE DENTAL TECHNOLOGIES, INC.

Rubber dam, non-latex

• Primary Device ID: 00850362007137
• NIH Device Record Key: 761f392f-ff57-423a-b89c-f7b97d3e0788
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KöR
• Version Model Number: KöR Dam
• Catalog Number: 80-1032
• Company DUNS: 005479970
• Company Name: EVOLVE DENTAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850362007137 [Primary]

FDA Product Code

• EIG: Retractor, All Types

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: 2021-05-26
• Device Publish Date: 2021-05-18

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.