FRESH Bold Impression Material 7067

GUDID 00815619021120

FRESH Bold Impression Material Bite Registration

EXACTA DENTAL PRODUCTS INC

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

• Primary Device ID: 00815619021120
• NIH Device Record Key: e864def0-1cb8-4322-910f-f587fa8c0993
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FRESH Bold Impression Material
• Version Model Number: Bite Registration
• Catalog Number: 7067
• Company DUNS: 016325552
• Company Name: EXACTA DENTAL PRODUCTS INC
• Device Count: 2
• 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	00815619020420 [Unit of Use]
GS1	00815619021120 [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: 2016-09-16

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