REFLECTYS FLOW FWTYS-B3

GUDID 03760260220378

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 ID03760260220378
NIH Device Record Key53c55ca2-bc7e-4136-b332-fc79a8dd7f25
Commercial Distribution StatusIn Commercial Distribution
Brand NameREFLECTYS FLOW
Version Model NumberB3
Catalog NumberFWTYS-B3
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
GS103760260220378 [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 [REFLECTYS FLOW]

03760260220378B3
03760260220361B2
03760260220354A3.5
03760260220347A3
03760260220330A2
03760260220323A1

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