Control Seal 1303

GUDID E22113031

Highly filled, transparent fissure sealant with fluoride, light curing

VOCO GmbH

Dental unfilled resin sealant/coating
Primary Device IDE22113031
NIH Device Record Keybd0de09b-1a21-4c08-9861-e19c76dfed2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameControl Seal
Version Model Number1303
Catalog Number1303
Company DUNS316699578
Company NameVOCO GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone999-999-9999
Emailxxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE22113031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBCSealant, Pit And Fissure, And Conditioner

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

Devices Manufactured by VOCO GmbH

E22162821 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite
E22162831 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, Kit 5x4.5g
E22162841 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A1
E22162851 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A2
E22162861 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A3
E22162871 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A3.5
E22162881 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A4
E22162891 - GrandioSO 4U2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, opaque

Trademark Results [Control Seal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CONTROL SEAL
CONTROL SEAL
79389154 not registered Live/Pending
Control Seal International B.V. (Besloten Vennootschap)
2023-09-27
CONTROL SEAL
CONTROL SEAL
79131294 4449625 Live/Registered
VOCO GmbH
2013-04-08

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