FastFix Sample Pack 006-00114

GUDID 00872320003272

Single-use sample pack of FastFix dental porcelain primer.

CAO GROUP, INC.

Dentine bonding agent/set

• Primary Device ID: 00872320003272
• NIH Device Record Key: ba910ed3-6bb7-419a-843f-f5281f805676
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FastFix Sample Pack
• Version Model Number: 006-00114
• Catalog Number: 006-00114
• Company DUNS: 102422578
• Company Name: CAO GROUP, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 40 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00872320003272 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091300

FDA Product Code

• KLE: Agent, Tooth Bonding, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-10

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