FDA.reportPublic FDA data

Ena Shiny

Primary DI
EMICESSF0
Brand
Ena Shiny
Company
MICERIUM SPA
Model
ESSF
Catalog number
ESSF
Device description
Ena Shiny Composite Finishing Strips 100 pcs Fine - Superfine Grain Strips "Standard"
Published
2021-12-07
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
EHMStrip, Polishing Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMICESSF1PrimaryHIBCC0
EMICESSF0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive strip, single-useA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ESUN3048Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46708Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46718Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46728Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46738Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46748Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46768Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46778Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46808Jiffy proximal sawDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUN46838Jiffy Diamond StripsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3541008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF354L8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF354LD8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3568Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF356L8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3638Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3648Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3668Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF37258Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3725BULK5008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3725LW8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3738Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF373D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3748Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374BULK5008Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF374LW8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF3768Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNF376D8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30
ESUNG30450MM8Sunshine DiamondsDr. Hopf GmbH & Co. KGEHM2023-06-30