Infinix Bulk Fill Flow Composite

GUDID 17290017528134

Dental Composite - A1 shade

NOBIO LTD

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Primary Device ID17290017528134
NIH Device Record Keyeaa693dd-5591-4511-8896-d6bf5c2e67b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameInfinix Bulk Fill Flow Composite
Version Model NumberINF-BF-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
GS107290017528106 [Primary]
GS117290017528134 [Package]
Contains: 07290017528106
Package: [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 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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