FDA.reportPublic FDA data

Ena Shiny

Primary DI
EMICESDX0
Brand
Ena Shiny
Company
MICERIUM SPA
Model
ESDX
Catalog number
ESDX
Device description
Ena Shiny Composite Finishing Discs 100 pcs Fine grain mini discs Max speed 10.000 rpm
Published
2021-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EHJDisk, Abrasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMICESDX1PrimaryHIBCC0
EMICESDX0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive disk, single-useA dental instrument consisting of a circular flat or slightly conical sheet, which may carry or contain an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns). It is designed to be fixed at its centre to a laboratory mandrel or lathe, and/or intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
436661136
Device count
100
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
EMICESG71Ena ShinyESG7ESG72021-02-12
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

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Primary DI, Brand, Company table
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00348783011982Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
00348783011999Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
00348783012019Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-27
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