Sapphire® Plus 033958000L

GUDID D813033958000L0

LT SAPPHIRE LOANER

DEN-MAT HOLDINGS, LLC

Dental/surgical polymerization lamp Dental/surgical polymerization lamp

• Primary Device ID: D813033958000L0
• NIH Device Record Key: e3e3a002-103b-43cb-a2e6-b70eea7bd874
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sapphire® Plus
• Version Model Number: 033958000L
• Catalog Number: 033958000L
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-433-6628
• Email: info@denmat.com
• Phone: 1-800-433-6628
• Email: info@denmat.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -30 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Storage Environment Temperature: Between -30 Degrees Fahrenheit and 125 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813033958000L0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081287

FDA Product Code

• EBZ: Activator, Ultraviolet, For Polymerization

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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• D8130339680000: LT SAPPHIRE PLUS
• D813033958000L0: LT SAPPHIRE LOANER
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• D8130339585030: LT SAPPHIRE 12mm TIP PKG
• D8130339585010: LT SAPPHIRE 4mm TIP PKG
• D8130305991050: DISPENSING GUN 25mL DCHMB SY
• D8130305972750: LT SAPH ROLLING STAND W/ARM
• D8130305953750: CRYSTAL ARM w/HLDR & PIVOT
• D8130303952500: SAPH WHT CRYSTAL KIT