Provicol QM 1109

GUDID E2211109

Eugenol-free temporary luting cement with calcium hydroxide.

VOCO GmbH

Fatty acid dental cement

• Primary Device ID: E2211109
• NIH Device Record Key: 3157540a-a26f-41a7-8dbb-6e8c6130bbef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Provicol QM
• Version Model Number: 1109
• Catalog Number: 1109
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	E2211109 [Unit of Use]
HIBCC	E22111091 [Primary]

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

On-Brand Devices [Provicol QM ]

• E22110741: Eugenol-free temporary luting cement with calcium hydroxide.
• E22110991: Eugenol-free temporary luting cement with calcium hydroxide.
• E2211109: Eugenol-free temporary luting cement with calcium hydroxide.