NuSmile Signature Anterior Replacement Crown

GUDID 00810118105449

NuSmile Signature Anterior Replacement Crown - Lateral, Size 5 Right - Short Length / Extra Light Shade

NUSMILE, LTD.

Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary
Primary Device ID00810118105449
NIH Device Record Key6de252a4-e2ba-4b6a-bead-38d7c52fb7b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuSmile Signature Anterior Replacement Crown
Version Model NumberB5R105XS
Company DUNS185497372
Company NameNUSMILE, LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810118105449 [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 Date2024-06-21
Device Publish Date2024-06-13

Devices Manufactured by NUSMILE, LTD.

00810118104565 - NuSmile Signature Anterior Replacement Crown 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 1 Right - Regular Length / Light Shade
00810118104572 - NuSmile Signature Anterior Replacement Crown2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 2 Right - Regular Length / Light Shade
00810118104589 - NuSmile Signature Anterior Replacement Crown2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 3 Right - Regular Length / Light Shade
00810118104596 - NuSmile Signature Anterior Replacement Crown2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 4 Right - Regular Length / Light Shade
00810118104602 - NuSmile Signature Anterior Replacement Crown 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 5 Right - Regular Length / Light Shade
00810118104619 - NuSmile Signature Anterior Replacement Crown2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 6 Right - Regular Length / Light Shade
00810118104626 - NuSmile Signature Anterior Replacement Crown 2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 1 Left - Regular Length / Light Shade
00810118104633 - NuSmile Signature Anterior Replacement Crown2024-06-21 NuSmile Signature Anterior Replacement Crown - Central, Size 2 Left - Regular Length / Light Shade

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.