FDA.reportPublic FDA data

Ena Shiny

Primary DI
EMICESG71
Brand
Ena Shiny
Company
MICERIUM SPA
Model
ESG7
Catalog number
ESG7
Device description
Ena ShinyShiny GAir Block7 x 0,5 ml
Published
2021-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EJRAgent, Polishing, Abrasive, Oral Cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJRAgent, Polishing, Abrasive, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMICESG71PrimaryHIBCC0
EMICESG70Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Professional dental abrasive materialA dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied by a healthcare professional with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices (e.g., restorations). It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, cleaning orthodontic appliances (bands and brackets), removing adhesive residue, and cleaning implants prior to loading. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature3 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
436661136
Device count
7
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EMICCOSZ251Ena Etch ®COSZ25COSZ252025-12-18
EMICESA01Ena ShinyESA0ESA02025-11-07
EMICESB01Ena ShinyESB0ESB02025-11-07
EMICCOS1010Ena Etch ®COS101COS1012018-11-16
EMICCOS101B0Ena Etch ®COS101BCOS101B2018-11-16
EMICCOSM1011Ena Etch ®COSM101COSM1012018-11-21
EMICCOSM101A1Ena Etch ®COSM101ACOSM101A2018-11-21
EMICCOSM101B1Ena Etch ®COSM101BCOSM101B2018-11-16
EMICCOSZ1001Ena Seal ®COSZ100COSZ1002018-11-21
EMICESG11Ena ShinyES+GES+G2024-08-06
EMICESYG0Ena ShinyES-Y+GES-Y+G2023-06-09
EMICESKIT01Ena ShinyESKITESKIT2023-06-08
EMICESA0Ena ShinyESAESA2021-02-12
EMICESA1Ena ShinyESAESA2021-02-12
EMICESB0Ena ShinyESBESB2021-02-12
EMICESB1Ena ShinyESBESB2021-02-12
EMICESC0Ena ShinyESCESC2021-02-12
EMICESC1Ena ShinyESCESC2021-02-12
EMICESC40Ena ShinyESC4ESC42021-02-12
EMICESC41Ena ShinyESC4ESC42021-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00353045003780QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045003797QartzDHARMA RESEARCH, INC.EJR2026-10-13
00353045000529QartzDHARMA RESEARCH, INC.EJR2026-10-12
00353045000536QartzDHARMA RESEARCH, INC.EJR2026-10-12
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00353045000581QartzDHARMA RESEARCH, INC.EJR2026-10-12
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00353045000512QartzDHARMA RESEARCH, INC.EJR2026-10-09
07613353171582AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.EJR2026-07-13