FDA.reportPublic FDA data

Easy Glaze

Primary DI
E22110161
Brand
Easy Glaze
Company
VOCO GmbH
Model
1016
Catalog number
1016
Device description
Easy Glaze is a nanofilled, light-cured coating with natural fluorescence forsealing surfaces.
Published
2019-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBDCoating, Filling Material, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBDCoating, Filling Material, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082285000EASY GLAZEVoco GmbH2008-10-24EBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E22110161PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental restorative material varnishA liquid substance used to cover dental filling material in the initial setting period after application typically to prevent moisture infiltration (especially when a dental silicate or glass ionomer cement is used as a filling material). The device typically consists of dissolved artificial resins. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius23 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags#

DUNS number
316699578
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E22122661VOCO Profluorid Varnish + BioMin226622662026-05-06
E22122671VOCO Profluorid Varnish + BioMin226722672026-05-06
E22122681VOCO Profluorid Varnish + BioMin226822682026-05-06
E22122691VOCO Profluorid Varnish + BioMin226922692026-05-06
E22122701VOCO Profluorid Varnish + BioMin227022702026-05-06
E22122711VOCO Profluorid Varnish + BioMin227122712026-05-06
E22122721VOCO Profluorid Varnish + BioMin227222722026-05-06
E22122731VOCO Profluorid Varnish + BioMin227322732026-05-06
E22122741VOCO Profluorid Varnish + BioMin227422742026-05-06
E22122761VOCO Profluorid Varnish + BioMin227622762026-05-06
E22122771VOCO Profluorid Varnish + BioMin227722772026-05-06
E22122781VOCO Profluorid Varnish + BioMin227822782026-05-06
E22122791VOCO Profluorid Varnish + BioMin227922792026-05-06
E22163141Grandio disc multicolor631463142026-04-30
E22163151Grandio disc multicolor631563152026-04-30
E22163161Grandio disc multicolor631663162026-04-30
E22163171Grandio disc multicolor631763172026-04-30
E22163181Grandio disc multicolor631863182026-04-30
E22163191Grandio disc multicolor631963192026-04-30
E22163231Grandio disc multicolor632363232026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E235Y00030SHOFU RESIN GLAZESHOFU DENTAL CORPORATIONEBD2026-06-08
08809896990288ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
08809896991056ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
08809896991063ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
00810184450030RodinPac-Dent, Inc.EBD2026-05-15
08809896990172ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990189ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990196ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990202ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990219ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990226ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990233ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990240ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990257ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990264ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990271ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990295ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990387ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990400ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990417ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990424ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990431ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990448ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990455ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990462ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990479ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990486ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990493ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990509ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990516ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14