Infinix Flowable Composite

GUDID 17290017528233

Dental Composite - A1 shade

NOBIO LTD

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 ID17290017528233
NIH Device Record Key147bd11e-d22f-4b11-97a1-ff26f239b886
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfinix Flowable Composite
Version Model NumberINF-FL-PP-MD-A1
Company DUNS532282466
Company NameNOBIO LTD
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
GS107290017528199 [Primary]
GS117290017528233 [Package]
Contains: 07290017528199
Package: carton box [1 Units]
In Commercial Distribution

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 Date2021-03-23
Device Publish Date2021-03-15

On-Brand Devices [Infinix Flowable Composite]

07290017528281Dental Composite - A3 shade Single dose
07290017528274Dental Composite - A2 shade Single dose
07290017528267Dental Composite - A1 shade Single dose
17290017528257Dental Composite - A3 shade Multi dose
17290017528240Dental Composite - A2 shade Multi dose 2g for re-fills kits
07290017528205Dental Composite - A2 shade Multi dose 1g for starter kit
17290017528233Dental Composite - A1 shade

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