Troposphere 1000117

GUDID H65810001171

Troposphere Powder Fine Cut

HENRY SCHEIN, INC.

Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam

• Primary Device ID: H65810001171
• NIH Device Record Key: 04e88254-c185-43a2-90cc-0cc64d86602b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Troposphere
• Version Model Number: 1000117
• Catalog Number: 1000117
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 5
• 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: 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: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0
• Weight: 5 Milligram
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H65810001171 [Primary]
HIBCC	H65810001178 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951865

FDA Product Code

• EJJ: Alloy, amalgam

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Troposphere]

• H65810092461: Troposphere 2 Spil 600mg 500 jar
• H65810075321: Troposphere 2 Spil 600mg 50 jar
• H65810040171: Troposphere 3 Spil 800mg 500 jar
• H65810037771: Troposphere Tablets Micro Cut
• H65810015281: Troposphere 1 Spil 400mg 500 jar
• H65810012351: Troposphere 3 Spil 800mg 50 jar
• H65810011851: Troposphere Tablets Micro Cut
• H65810011811: Troposphere 1 Spil 400mg 50 jar
• H65810001171: Troposphere Powder Fine Cut
• H65810000371: Troposphere Powder Fine Cut