DENTOCORE DCB-50

GUDID 03760260222037

ITENA CLINICAL

Dental composite resin
Primary Device ID03760260222037
NIH Device Record Key79aeaea4-eab6-4de2-86f8-31d44c403404
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENTOCORE
Version Model NumberCartridge white shade
Catalog NumberDCB-50
Company DUNS278261221
Company NameITENA CLINICAL
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760260222037 [Primary]

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 Date2022-11-10
Device Publish Date2016-10-15

On-Brand Devices [DENTOCORE ]

03760260222044Cartridge A3 shade
03760260222037Cartridge white shade
03760260222006Automix

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