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Ena Shiny

FDA UDI

Class I (US FDA UDI)

by Micerium Spa

Identity

Trade Name
Ena Shiny FDA UDI
Generic Name
Dental abrasive point, single-use FDA UDI
Device Name
Ena Shiny Shiny 13 Blue RA 12 pcs Rubber Points, Composite polishing Max Speed 10.000 rpm FDA UDI
Model / Reference
ES13 FDA UDI
Description
Ena Shiny Shiny 13 Blue RA 12 pcs Rubber Points, Composite polishing Max Speed 10.000 rpm FDA UDI

Identifiers

Catalog Number
ES13 FDA UDI
Primary DI / UDI-DI
EMICES131 FDA UDI
FDA Product Code
EHL FDA UDI
GMDN Term
Dental abrasive point, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental abrasive point, single-use

Ena Shiny by Micerium Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental abrasive point, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Micerium Spa

Sources (1)

  • FDA UDI 4143ee54-b544-4ea3-9251-c19713a4f159 34 fields · synced May 31, 2026