Infinix Bulk Fill Flow Composite

GUDID 07290017528168

Dental Composite - A1 shade Single dose

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 ID07290017528168
NIH Device Record Keyd28ed153-44e0-40b8-9255-3c8ce7c3464d
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfinix Bulk Fill Flow Composite
Version Model NumberINF-BF-FP-SD-A1
Company DUNS532282466
Company NameNOBIO LTD
Device Count15
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS107290017528168 [Unit of Use]
GS117290017528165 [Primary]

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 Bulk Fill Flow Composite]

07290017528434Dental Composite - Translucent Single dose
07290017528182Dental Composite - A3 shade Single dose
07290017528175Dental Composite - A2 shade Single dose
07290017528168Dental Composite - A1 shade Single dose
17290017528424Dental Composite - Translucent
17290017528158Dental Composite - A3 shade
17290017528141Dental Composite - A2 shade
17290017528134Dental Composite - A1 shade

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