NuSmile BioFlx Anterior Central and Lateral - Mini Kit

GUDID 00810118105524

NuSmile BioFlx Anterior Central and Lateral - Mini Kit - 20 Crowns

NUSMILE, LTD.

Preformed dental crown, temporary
Primary Device ID00810118105524
NIH Device Record Key509d4087-2ccb-4f79-9ae9-e3dcef43d3e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuSmile BioFlx Anterior Central and Lateral - Mini Kit
Version Model NumberMN404C
Company DUNS185497372
Company NameNUSMILE, LTD.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com
Phone7138610033
Emailsmunoz@nusmile.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810118105524 [Primary]

FDA Product Code

ELZCrown, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-22
Device Publish Date2024-08-14

Devices Manufactured by NUSMILE, LTD.

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00810118105647 - Avalon Biomed by Zarc Z-Fit Gutta Percha - Wide 302025-02-06 60 units
00810118105654 - Avalon Biomed by Zarc Z-Fit Sterile Paper Points - Narrow 152025-02-06 180 units
00810118105661 - Avalon Biomed by Zarc Z-Fit Sterile Paper Points - Wide 302025-02-06 180 units
00810118105678 - NuSmile Pre-Contoured Stainless Steel Crown2024-12-23 NuSmile Pre-Contoured Stainless Steel Crown - First Primary Molar, Maxillary Left, Size 5
00810118105685 - NuSmile Pre-Contoured Stainless Steel Crown2024-12-23 NuSmile Pre-Contoured Stainless Steel Crown - First Primary Molar, Maxillary Right, Size 5
00810118105692 - NuSmile Pre-Contoured Stainless Steel Crown2024-12-23 NuSmile Pre-Contoured Stainless Steel Crown - Second Primary Molar, Maxillary Left, Size 3

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