Bisfil-II Cat 14gm A-1231P

GUDID D757A1231P0

BISCO INC.

Dental composite resin

• Primary Device ID: D757A1231P0
• NIH Device Record Key: 617f852d-29aa-4347-ad96-e42d7571cbad
• Commercial Distribution Discontinuation: 2019-04-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Bisfil-II Cat 14gm
• Version Model Number: A-1231P
• Catalog Number: A-1231P
• Company DUNS: 053529939
• Company Name: BISCO 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: +1(847)534-6000
• Email: sales@bisco.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D757A1231P0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K853002

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-04
• Device Publish Date: 2017-06-12

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