Ena Tender ® ETPKIT

GUDID EMICETPKIT0

Ena Tender Pink Kit 4 colours x 2.5 g: Pink, Pink Dark, Pink Light, Pink Transparent 1 Pink Paste Opaque x 1g 3 Stain x 3g: White, Blue, Red

MICERIUM SPA

Dental composite resin
Primary Device IDEMICETPKIT0
NIH Device Record Key502f77cc-96f6-443e-b829-446457cb8a43
Commercial Distribution StatusIn Commercial Distribution
Brand NameEna Tender ®
Version Model NumberETPKIT
Catalog NumberETPKIT
Company DUNS436661136
Company NameMICERIUM SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Weight20 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEMICETPKIT0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-15

On-Brand Devices [Ena Tender ®]

EMICETPKIT1Ena Tender Pink Kit 4 colours x 2.5 g: Pink (THP), Pink Dark (THPD), Pink Light (THPL), Pink Tra
EMICETPKIT0Ena Tender Pink Kit 4 colours x 2.5 g: Pink, Pink Dark, Pink Light, Pink Transparent 1 Pink Past
EMICETPT1ENA TENDER PINK TRANSPARENT, 5g
EMICETPT0ENA TENDER PINK TRANSPARENT, 5g
EMICETPL1ENA TENDER PINK LIGHT, 5g
EMICETPD1ENA TENDER PINK DARK, 5g
EMICETOP1ENA Tender paste opaque pink 3g
EMICETOL1ENA TENDER PASTE OPAQUE light, 3g
EMICETOD1ENA TENDER PASTE OPAQUE dark, 3g

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.