Ena Bond ® COSM300P

GUDID EMICCOSM300P1

ENA-BOND TOTAL ETCH BONDING 3 steps promo kit 1 COSM300A2 Ena Bond Light Curing Primer (2 ml) 1 COSZ10-2 Ena Seal Light Curing Resin (2,5 ml) 1 COS101 Ena Etch 37% (2 ml)

MICERIUM SPA

Dentine bonding agent/set
Primary Device IDEMICCOSM300P1
NIH Device Record Key6322257a-0979-4bd6-a9c0-83d03b6b53da
Commercial Distribution StatusIn Commercial Distribution
Brand NameEna Bond ®
Version Model NumberCOSM300P
Catalog NumberCOSM300P
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 Kittrue
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

Total Volume6.5 Milliliter
Total Volume6.5 Milliliter
Total Volume6.5 Milliliter
Total Volume6.5 Milliliter
Total Volume6.5 Milliliter
Total Volume6.5 Milliliter
Total Volume6.5 Milliliter
Total Volume6.5 Milliliter
Total Volume6.5 Milliliter
Total Volume6.5 Milliliter
Total Volume6.5 Milliliter
Total Volume6.5 Milliliter
Total Volume6.5 Milliliter
Total Volume6.5 Milliliter

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEMICCOSM300P1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHAdhesive, Bracket And Tooth Conditioner, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-17
Device Publish Date2018-11-16

On-Brand Devices [Ena Bond ®]

EMICCOSM300P1ENA-BOND TOTAL ETCH BONDING 3 steps promo kit 1 COSM300A2 Ena Bond Light Curing Primer (2 ml) 1
EMICCOSM300K1ENA-BOND BI COMPONENT INTRO KIT Etch & Rinse Two-Component Bonding System 1 COSM300A Ena Bond L
EMICCOSM300D1ENA-BOND CATALYST 5ml
EMICCOSM300D0ENA-BOND CATALYST 5ml
EMICCOSM300A20ENA-BOND ONE COMPONENT BONDING 2ml
EMICCOSM300A1ENA-BOND ONE COMPONENT BONDING 5ml
EMICCOSM3001ENA-BOND ONE COMPONENT BONDING KIT Light curing one component Bonding System 1 COSM300A Ena Bond
EMICCFOTX1ENA-BOND SE KIT Bonding + Primer -1 CFOTS-2 (2 ml) -1 CFOTP-2 (2 ml)
EMICCFOTS20ENA-BOND SE LIGHT CURING BONDING 2 ml
EMICCFOTS1ENA-BOND SE LIGHT CURING BONDING 5 ml
EMICCFOTS0ENA-BOND SE LIGHT CURING BONDING 5 ml
EMICCFOTP20ENA-BOND SE Primer 2 ml
EMICCFOTP1ENA-BOND SE Primer 5 ml
EMICCFOTP0ENA-BOND SE Primer 5 ml
EMICCFOTK1ENA-BOND SE BONDING KIT Adesive + Primer + Etching Gel -1 CFOTS (5 ml) -1 CFOTP (5 ml) -1 COS101
EMICCFOT1ENA-BOND SE KIT Bonding + Primer -1 CFOTS (5 ml) -1 CFOTP (5 ml)
EMICCOSM3M11ENA-BOND applicators, medium, blue 1pc
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