FRESH Bold Impression Material 1-7486

GUDID 00815619020536

EXACTA DENTAL PRODUCTS INC

Silicone dental impression material

• Primary Device ID: 00815619020536
• NIH Device Record Key: 3f175acb-76fb-43b9-9692-56201fd40e92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FRESH Bold Impression Material
• Version Model Number: Monophase Cartridge
• Catalog Number: 1-7486
• Company DUNS: 016325552
• Company Name: EXACTA DENTAL PRODUCTS 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815619020536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053427

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: 2016-09-23

On-Brand Devices [FRESH Bold Impression Material]

• 00815619021403: FRESH Bold Impression Material Light Body Bulk
• 00815619021397: FRESH Bold Impression Material Light Body Fast Set
• 00815619021380: FRESH Bold Impression Material Monophase Fast Set
• 00815619021373: FRESH Bold Impression Material Monophase Fast Set
• 00815619021366: FRESH Bold Impression Material Liquid Putty Bulk
• 00815619021359: FRESH Bold Impression Material Liquid Putty
• 00815619021342: FRESH Bold Impression Material Clear Bite Bulk
• 00815619021335: FRESH Bold Impression Material Clear Bite
• 00815619021328: FRESH Bold Impression Material Heavy Body Fast Set Bulk
• 00815619021311: FRESH Bold Impression Material Heavy Body Fast Set
• 00815619021304: FRESH Bold Impression Material Medium Body Fast Set Bulk
• 00815619021298: FRESH Bold Impression Material Medium Body Fast Set
• 00815619021274: FRESH Bold Impression Material Monophase Bulk
• 00815619021267: FRESH Bold Impression Material Monophase
• 00815619021137: FRESH Bold Impression Material Bite Registration Bulk
• 00815619021120: FRESH Bold Impression Material Bite Registration
• 00815619020888: FRESH Bold Impression Material Putty
• 00815619020871: FRESH Bold Impression Material Heavy Body Mega Pack
• 00815619020628: FRESH Bold Impression Material Blu Max Bite Registration Cartridge
• 00815619020604: FRESH Bold Impression Material Light Body Fast Set Cartridge
• 00815619020598: FRESH Bold Impression Material Monophase Fast Set Cartridge
• 00815619020581: FRESH Bold Impression Material Clear Liquid Putty Cartridge
• 00815619020574: FRESH Bold Impression Material Clear Bite Cartridge
• 00815619020567: FRESH Bold Impression Material Heavy Body Cartridge
• 00815619020550: FRESH Bold Impression Material Medium Body Cartridge
• 00815619020536: Monophase Cartridge
• 00815619020420: FRESH Bold Impression Material Bite Registration Cartridge