Ena HRI ® EHTSF1

GUDID EMICEHTSF10

Ena HRi Ena Soft Flow Color Dentine 3 g

MICERIUM SPA

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device IDEMICEHTSF10
NIH Device Record Keya36da352-b175-4827-a86c-237b80d2e4f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameEna HRI ®
Version Model NumberEHTSF1
Catalog NumberEHTSF1
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram
Weight7.5 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 3 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEMICEHTSF10 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-16
Device Publish Date2023-06-08

On-Brand Devices [Ena HRI ®]

EMICETST1Ena HRi Stain Flow Transparent 2g Light Curing Composite
EMICETST0Ena HRi Stain Flow Transparent 2g Light Curing Composite
EMICERUE31Ena HRi Enamel UE3 2.5g Light Curing Composite
EMICERUE30Ena HRi Enamel UE3 2.5g Light Curing Composite
EMICERUE21Ena HRi Enamel UE2 2.5g Light Curing Composite
EMICERUE20Ena HRi Enamel UE2 2.5g Light Curing Composite
EMICERUE11Ena HRi Enamel UE1 2.5g Light Curing Composite
EMICERUE10Ena HRi Enamel UE1 2.5g Light Curing Composite
EMICERUD51Ena HRi Dentin UD5 2.5g Light Curing Composite
EMICERUD50Ena HRi Dentin UD5 2.5g Light Curing Composite
EMICERUD41Ena HRi Dentin UD4 2.5g Light Curing Composite
EMICERUD40Ena HRi Dentin UD4 2.5g Light Curing Composite
EMICERUD351Ena HRi Dentin UD3,5 2.5g Light Curing Composite
EMICERUD350Ena HRi Dentin UD3,5 2.5g Light Curing Composite
EMICERUD31Ena HRi Dentin UD3 2.5g Light Curing Composite
EMICERUD30Ena HRi Dentin UD3 2.5g Light Curing Composite
EMICERUD21Ena HRi Dentin UD2 2.5g Light Curing Composite
EMICERUD20Ena HRi Dentin UD2 2.5g Light Curing Composite
EMICERUD11Ena HRi Dentin UD1 2.5g Light Curing Composite
EMICERUD10Ena HRi Dentin UD1 2.5g Light Curing Composite
EMICERUD051Ena HRi Dentin UD0,5 2.5g Light Curing Composite
EMICERUD050Ena HRi Dentin UD0,5 2.5g Light Curing Composite
EMICERUD01Ena HRi Dentin UD0 2.5g Light Curing Composite
EMICERUD00Ena HRi Dentin UD0 2.5g Light Curing Composite
EMICERIWS1Ena HRi Enamel IWS Intensive White Spot 2.5g Light Curing Composite
EMICERIWS0Ena HRi Enamel IWS Intensive White Spot 2.5g Light Curing Composite
EMICERIW1Ena HRi Enamel IW Intensive White 2.5g Light Curing Composite
EMICERIW0Ena HRi Enamel IW Intensive White 2.5g Light Curing Composite
EMICEREF31Ena HRi Enamel Function EF3 2.5g Light Curing Composite
EMICEREF30Ena HRi Enamel Function EF3 2.5g Light Curing Composite
EMICEREF21Ena HRi Enamel Function EF2 2.5g Light Curing Composite
EMICEREF20Ena HRi Enamel Function EF2 2.5g Light Curing Composite
EMICEREF11Ena HRi Enamel Function EF1 2.5g Light Curing Composite
EMICEREF10Ena HRi Enamel Function EF1 2.5g Light Curing Composite
EMICERBF31HRi Bio Function Enamel BF3 2,5g Light Curing Composite
EMICERBF30Ena HRi Bio Function Enamel BF3 2.5g Light Curing Composite
EMICERBF21HRi Bio Function Enamel BF2 2,5g Light Curing Composite
EMICERBF20Ena HRi Bio Function Enamel BF2 2.5g Light Curing Composite
EMICERBF11HRi Bio Function Enamel BF1 2,5g Light Curing Composite
EMICERBF10Ena HRi Bio Function Enamel BF1 2.5g Light Curing Composite
EMICERBD40Ena HRi Bio Dentine BD4 2.5g Light Curing Composite
EMICERBD30Ena HRi Bio Dentine BD3 2.5g Light Curing Composite
EMICERBD20Ena HRi Bio Dentine BD2 2.5g Light Curing Composite
EMICERBD10Ena HRi Bio Dentine BD1 2.5g Light Curing Composite
EMICER3FC1Ena HRi Function Enamel Kit 2.5g x 3 colors: EREF1, EREF2, EREF3 Posterior Enamel Light Curing
EMICER3FC0Ena HRi Function Enamel Kit 2.5g x 3 colors EF1, EF2, EF3 Posterior Enamel Light Curing Composit
EMICER3FB1Ena HRi Bio Function Enamel Kit 2.5g x 3 colors: ERBF1, ERBF2, ERBF3 Posterior Enamel Light Cur
EMICER3FB0Ena HRi Bio Function Enamel Kit 2.5g x 3 colors BF1, BF2, BF3 Posterior Enamel Light Curing Comp
EMICER3E1Ena HRi Enamel Kit 2.5g x 3 colors ERUE1, ERUE2, ERUE3 Light Curing Composite
EMICER3E0Ena HRi Enamel Kit 2.5g x 3 colors UE1, UE2, UE3 Light Curing Composite
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.