TOTAL C-RAM TTCRAM-TR

GUDID 03760260221061

ITENA CLINICAL

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device ID03760260221061
NIH Device Record Keyb8d3d3d0-5868-4552-bfe5-11b7c1c39147
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOTAL C-RAM
Version Model NumberTRANSLUCENT
Catalog NumberTTCRAM-TR
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
GS103760260221061 [Primary]

FDA Product Code

EMACement, Dental

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 Date2017-06-11

On-Brand Devices [TOTAL C-RAM]

03760260221207TRANSLUCENT
03760260221078OPAQUE
03760260221061TRANSLUCENT

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