Porcelain Primer B-2221

GUDID 10810111540114

PORCELAIN PRIMER 10ml

BISCO INC.

Dental prosthesis priming agent

• Primary Device ID: 10810111540114
• NIH Device Record Key: b3546dfd-a181-42e0-a271-545520dcad0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Porcelain Primer
• Version Model Number: B-2221
• Catalog Number: B-2221
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810111540117 [Primary]
GS1	10810111540114 [Package]; Contains: 00810111540117; Package: [1 Units]; In Commercial Distribution
HIBCC	D757B22210 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K874557

FDA Product Code

• EBC: SEALANT, PIT AND FISSURE, AND CONDITIONER

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: 2022-10-10
• Device Publish Date: 2022-09-30

On-Brand Devices [Porcelain Primer]

• D757B2223P0: Porcelain Primer 3ml Btl
• D757B2221P1: PORCELAIN PRIMER 10ml Pkg
• D757B22210: PORCELAIN PRIMER 10ml
• 10810111540114: PORCELAIN PRIMER 10ml
• 00810111540124: Porcelain Primer 3ml Btl