FDA.reportPublic FDA data

VITA ENAMIC GLAZE

Primary DI
E239M700101
Brand
VITA ENAMIC GLAZE
Company
Innovation MediTech GmbH
Model
1
Catalog number
M70010
Device description
Light-curing dental lacquer for final coating of shade customization/characterization of the surface of dental restorations. 20 ml bottle.
Published
2016-10-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K123761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123761000VITA ENAMIC STAINSInnovation Meditech GmbH2013-03-01EBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E239M700101PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymer-based dental model materialA variety of dental materials dedicated for modelling and for use during production of dental restorations. It is based on various kinds of polymers. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313785693
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D239206411egger A/ITE vario20641206412025-08-29
E2392064111egger A/ITE vario2064112064112025-08-29
E239M700111VITA ENAMIC STAINS LIQUID1M700112016-10-18
E239M7001211VITA ENAMIC STAIN white1M7001212016-10-18
E239M7001221VITA ENAMIC STAIN corn1M7001222016-10-18
E239M7001231VITA ENAMIC STAIN brown1M7001232016-10-18
E239M7001241VITA ENAMIC STAIN blue1M7001242016-10-18
E239M7001251VITA ENAMIC STAIN black1M7001252016-10-18
E239M7001261VITA ENAMIC STAIN khaki1M7001262016-10-18
E239M1113001 Sonopal® hard Lacquer AlM111300M1113002020-09-21
E239M1113031Sonopal® hard Lacquer Al M111303M1113032020-09-21
E239M1113041Sonopal® hard Lacquer AlM111304M1113042020-09-21
E239M1113091Sonopal® hard Lacquer AlM111309M1113092020-09-21
E239M1115041Sonopal® soft Lacquer EM111504M1115042020-09-21
E239M1115051Sonopal® soft Lacquer EM111505M1115052020-09-21
E239M1115071Sonopal® soft Lacquer EM111507M1115072020-09-21

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