Perfectemp®10 CR1219

GUDID D813CR12190

PERFECTEMP10 10mL SYR A3.5

DEN-MAT HOLDINGS, LLC

Dental composite resin

• Primary Device ID: D813CR12190
• NIH Device Record Key: ac75a8e5-9d87-49bb-985a-1eaecc5b7f7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perfectemp®10
• Version Model Number: CR1219
• Catalog Number: CR1219
• 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: 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

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

• Special Storage Condition, Specify: Between 0 and 0 *Do not store in a refrigerator
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in a refrigerator
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in a refrigerator
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in a refrigerator
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in a refrigerator
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 64 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store in a dry place
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to extreme temperature fluctuations
• Special Storage Condition, Specify: Between 0 and 0 *Do not store in a refrigerator

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813CR12190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122039

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 [Perfectemp®10]

• D813SPD13090: PERFECTEMP10 50mL CART BL-2
• D813SPD13080: PERFECTEMP10 50mL CART B1
• D813SPD13070: PERFECTEMP10 50mL CART A3.5
• D813SPD13060: PERFECTEMP10 50mL CART A2
• D813SPD13050: PERFECTEMP10 50mL CART A1
• D813CR12200: PERFECTEMP10 10mL SYR A2
• D813CR12190: PERFECTEMP10 10mL SYR A3.5
• D813CR12180: PERFECTEMP10 10mL SYR A1