Control Seal 1303

GUDID E22113031

Highly filled, transparent fissure sealant with fluoride, light curing

VOCO GmbH

Dental unfilled resin sealant/coating

• Primary Device ID: E22113031
• NIH Device Record Key: bd0de09b-1a21-4c08-9861-e19c76dfed2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control Seal
• Version Model Number: 1303
• Catalog Number: 1303
• 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

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	E22113031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130485

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

Devices Manufactured by VOCO GmbH

• E22162701 - GrandioSO Unlimited: 2025-09-08 light-curing, radiopaque nano-hybrid universal composite, Set Caps 75x0.3g
• E22162761 - GrandioSO Unlimited: 2025-09-08 light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.3g, opaque
• E22162771 - GrandioSO Unlimited: 2025-09-08 light-curing, radiopaque nano-hybrid universal composite, Caps 15x0.3g, BL
• E22162941 - GrandioSO 4U: 2025-08-22 light-curing, radiopaque nano-hybrid universal composite, Set Caps 45x0.4g
• E22116451 - MTA vpt: 2025-07-15 biocompatible, radiopaque, hydraulic, self-curing cement.
• E22162821 - GrandioSO 4U: 2025-06-10 light-curing, radiopaque nano-hybrid universal composite
• E22162831 - GrandioSO 4U: 2025-06-10 light-curing, radiopaque nano-hybrid universal composite, Kit 5x4.5g
• E22162841 - GrandioSO 4U: 2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A1