Provicol QM Aesthetic 1108

GUDID E22111081

Eugenol-free temporary luting cement with calcium hydroxide.

VOCO GmbH

Fatty acid dental cement

• Primary Device ID: E22111081
• NIH Device Record Key: 1e553d09-81b0-4586-8e58-5cc5bdab9f06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provicol QM Aesthetic
• Version Model Number: 1108
• Catalog Number: 1108
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22111081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201856

FDA Product Code

• EMA: Cement, Dental

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: 2020-09-07
• Device Publish Date: 2020-08-28

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• E22162851 - GrandioSO 4U: 2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A2
• E22162861 - GrandioSO 4U: 2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A3
• E22162871 - GrandioSO 4U: 2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A3.5
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