Nuance® CR1135

GUDID D813CR11350

NUANCE A1 UNIV COMPULE

DEN-MAT HOLDINGS, LLC

Dental composite resin Dental composite resin

• Primary Device ID: D813CR11350
• NIH Device Record Key: 4f4b31a6-a2e0-4363-b917-80e12fd65b14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nuance®
• Version Model Number: CR1135
• Catalog Number: CR1135
• 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: 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: 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 *After extrusion, securely place the cap onto the syringe. This will protect Nuance from ambient light, as well as foreign objects.
• Special Storage Condition, Specify: Between 0 and 0 *After extrusion, securely place the cap onto the syringe. This will protect Nuance from ambient light, as well as foreign objects.
• Special Storage Condition, Specify: Between 0 and 0 *After extrusion, securely place the cap onto the syringe. This will protect Nuance from ambient light, as well as foreign objects.
• Special Storage Condition, Specify: Between 0 and 0 *After extrusion, securely place the cap onto the syringe. This will protect Nuance from ambient light, as well as foreign objects.
• Special Storage Condition, Specify: Between 0 and 0 *After extrusion, securely place the cap onto the syringe. This will protect Nuance from ambient light, as well as foreign objects.
• Handling Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Nuance FLOW should not be used past the expiration date listed on the syringe.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight, extreme heat or open flame.
• Special Storage Condition, Specify: Between 0 and 0 *After extrusion, securely place the cap onto the syringe. This will protect Nuance from ambient light, as well as foreign objects.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813CR11350 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101215

FDA Product Code

• EBF: Material, Tooth Shade, 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 [Nuance®]

• D813CR12170: NUANCE FLOW A1 SYR NEW
• D813CR12150: NUANCE FLOW A2 SYR NEW
• D813CR12140: NUANCE FLOW A3 SYR NEW
• D813CR12130: NUANCE FLOW A3.5 SYR NEW
• D813CR12120: NUANCE FLOW B1 SYR NEW
• D813CR12100: NUANCE FLOW BL1 SYR NEW
• D813CR12090: NUANCE FLOW BL2 SYR NEW
• D813CR11550: NUANCE OA2 UNIV COMPULE
• D813CR11460: NUANCE C3 UNIV COMPULE
• D813CR11430: NUANCE B2 UNIV COMPULE
• D813CR11420: NUANCE B1 UNIV COMPULE
• D813CR11400: NUANCE BL UNIV COMPULE
• D813CR11380: NUANCE A3.5 UNIV COMPULE
• D813CR11370: NUANCE A3 UNIV COMPULE
• D813CR11360: NUANCE A2 UNIV COMPULE
• D813CR11350: NUANCE A1 UNIV COMPULE
• D813CR11210: NUANCE OA2 UNIVERSAL SYR
• D813CR11120: NUANCE C3 UNIVERSAL SYR
• D813CR11090: NUANCE B2 UNIVERSAL SYR
• D813CR11080: NUANCE B1 UNIVERSAL SYR
• D813CR11060: NUANCE BL UNIVERSAL SYR
• D813CR11040: NUANCE A3.5 UNIVERSAL SYR
• D813CR11030: NUANCE A3 UNIVERSAL SYR
• D813CR11020: NUANCE A2 UNIVERSAL SYR
• D813CR11010: NUANCE A1 UNIVERSAL SYR