ResinBlend LV Composite Blending Resin Unit Dose 970151

GUDID 00359883001421

Dental unfilled resin sealant/coating

DEN-MAT HOLDINGS, LLC

Dental unfilled resin sealant/coating

• Primary Device ID: 00359883001421
• NIH Device Record Key: e334dd4a-c68a-4658-a665-91d81ae18dc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ResinBlend LV Composite Blending Resin Unit Dose
• Version Model Number: 970151
• Catalog Number: 970151
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• Device Count: 1
• DM Exempt: true
• 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
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com
• Phone: +1(800)433-6628
• Email: info@denmat.com

Device Dimensions

• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter
• Total Volume: 0.1 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Store in a well-ventilated place. Keep cool.
• Storage Environment Temperature: Between 18 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00359883001421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092539

FDA Product Code

• EBF: Material, tooth shade, resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-20
• Device Publish Date: 2025-03-12

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