Image Tooth Shade Acrylic 2282568

GUDID 00304040001042

Image Tooth Shade Acrylic

HENRY SCHEIN, INC.

Dental crown/bridge resin, temporary

• Primary Device ID: 00304040001042
• NIH Device Record Key: ff4ed759-14ad-4e72-ad33-958789352d41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Image Tooth Shade Acrylic
• Version Model Number: 2282568
• Catalog Number: 2282568
• 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

• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius
• 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.
• Storage Environment Temperature: Between 2 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040001042 [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

On-Brand Devices [Image Tooth Shade Acrylic]

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• 00304040001165: Image Tooth Shade Acrylic
• 00304040001158: Image Tooth Shade Acrylic
• 00304040001141: Image Tooth Shade Acrylic
• 00304040001134: Image Tooth Shade Acrylic
• 00304040001127: Image Tooth Shade Acrylic
• 00304040001110: Image Tooth Shade Acrylic
• 00304040001103: Image Tooth Shade Acrylic
• 00304040001097: Image Tooth Shade Acrylic
• 00304040001080: Image Tooth Shade Acrylic
• 00304040001073: Image Tooth Shade Acrylic
• 00304040001066: Image Tooth Shade Acrylic
• 00304040001059: Image Tooth Shade Acrylic
• 00304040001042: Image Tooth Shade Acrylic
• 00304040001035: Image Tooth Shade Acrylic
• 00304040001028: Image Tooth Shade Acrylic
• 00304040001011: Image Tooth Shade Acrylic
• 00304040000991: Image Tooth Shade Acrylic
• 00304040000984: Image Tooth Shade Acrylic