Quantium H-10120K

GUDID 00810111543293

Quantium Unit Dose Kit w/ Select HV Etch w/o BAC

BISCO INC.

Dental composite resin

• Primary Device ID: 00810111543293
• NIH Device Record Key: 58b0b8e8-4033-4f9f-8790-e47ac862f267
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantium
• Version Model Number: H-10120K
• Catalog Number: H-10120K
• Company DUNS: 053529939
• Company Name: BISCO INC.
• 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: 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(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810111543293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242816

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: 2025-07-22
• Device Publish Date: 2025-07-14

On-Brand Devices [Quantium]

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• 00810111543309: Quantium Syringe Kit w/ Select HV Etch w/BAC
• 00810111543293: Quantium Unit Dose Kit w/ Select HV Etch w/o BAC
• 00810111543286: Quantium Unit-Dose Kit w/ Select HV Etch w/BAC
• 10810111543276: Quantium A2 Body and A2 Enamel Unit Dose Sample (0.25g each)
• 10810111543269: Quantium Bleach Unit Dose (0.25g)
• 10810111543252: Quantium Incisal Unit Dose (0.25g)
• 10810111543245: Quantium B2 Enamel Unit Dose (0.25g)
• 10810111543238: Quantium B1 Enamel Unit Dose (0.25g)
• 10810111543221: Quantium A3.5 Enamel Unit Dose (0.25g)
• 10810111543214: Quantium A3 Enamel Unit Dose (0.25g)
• 10810111543207: Quantium A2 Enamel Unit Dose (0.25g)
• 10810111543191: Quantium A1 Enamel Unit Dose (0.25g)
• 10810111543184: Quantium B2 Body Unit Dose (0.25g)
• 10810111543177: Quantium B1 Body Unit Dose (0.25g)
• 10810111543160: Quantium A3.5 Body Unit Dose (0.25g)
• 10810111543153: Quantium A3 Body Unit Dose (0.25g)
• 10810111543146: Quantium A2 Body Unit Dose (0.25g)
• 10810111543139: Quantium A1 Body Unit Dose (0.25g)
• 10810111543122: Quantium Incisal 4g Syringe
• 10810111543115: Quantium B2 Enamel 4g Syringe
• 10810111543108: Quantium B1 Enamel 4g Syringe
• 10810111543092: Quantium A3.5 Enamel 4g Syringe
• 10810111543085: Quantium A3 Enamel 4g Syringe
• 10810111543078: Quantium A2 Enamel 4g Syringe
• 10810111543061: Quantium A1 Enamel 4g Syringe
• 10810111543054: Quantium Bleach 4g Syringe
• 10810111543047: Quantium B2 Body 4g Syringe
• 10810111543030: Quantium B1 Body 4g Syringe
• 10810111543023: Quantium A3.5 Body 4g Syringe
• 10810111543016: Quantium A3 Body 4g Syringe
• 10810111543009: Quantium A2 Body 4g Syringe
• 10810111542996: Quantium A1 Body 4g Syringe
• 00810111543347: Quantium A2 Body & A2 Enamel Syringe (1g each) Sample Package
• 00810111543330: Quantium A2 Enamel 1g Syringe
• 00810111543323: Quantium A2 Body 1g Syringe