VOCO Ionofil Molar AC Quick 1630

GUDID E22116301

Glass ionomer restorative material. This set contains 48 application capsules (8 X A1, 8 X A2, 32 X A3) and Final Varnish LC bottle 3 ml.

VOCO GmbH

Glass ionomer dental cement

• Primary Device ID: E22116301
• NIH Device Record Key: 399edc44-de73-42be-88a4-e2de40c241e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VOCO Ionofil Molar AC Quick
• Version Model Number: 1630
• Catalog Number: 1630
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• Device Count: 48
• 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

Customer Support Contacts

• Phone: 999-999-9999
• Email: xxx@xx.xx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22116300 [Unit of Use]
HIBCC	E22116301 [Primary]

FDA Product Code

• EMA: Cement, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-31

On-Brand Devices [VOCO Ionofil Molar AC Quick]

• E22116341: 1634
• E22116321: 1632
• E22116311: 1631
• E22116301: Glass ionomer restorative material. This set contains 48 application capsules (8 X A1, 8 X A2, 3
• E22114691: Glass ionomer restorative material. The set contains 20 application capsules A3, AC Activator an