Image Tooth Shade Acry 2282583

GUDID 00304040001004

Image Tooth Shade Acry

HENRY SCHEIN, INC.

Dental crown/bridge resin, temporary

• Primary Device ID: 00304040001004
• NIH Device Record Key: 56c49a9a-83bf-4336-a129-12ef64b85a51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Image Tooth Shade Acry
• Version Model Number: 2282583
• Catalog Number: 2282583
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, 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: true
• 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 Dimensions

• Weight: 125 Gram
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram
• Device Size Text, specify: 0
• Weight: 125 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Storage this product at room temperature, in a cool area.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040001004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102874

FDA Product Code

• EBG: CROWN AND BRIDGE, TEMPORARY, 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: 2016-09-24

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