NuSmile BioFlx Narrow - First Primary Molar - Starter Kit

GUDID 00810118105548

NuSmile BioFlx Narrow - First Primary Molar - Starter Kit - 32 Crowns

NUSMILE, LTD.

Preformed dental crown, temporary
Primary Device ID00810118105548
NIH Device Record Key7ad49186-580b-4537-8aac-d18e2cc5392f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuSmile BioFlx Narrow - First Primary Molar - Starter Kit
Version Model NumberSKD407L
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
GS100810118105548 [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

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