NuSmile ReVIVE Crowns

GUDID 00810118106989

NuSmile ReVIVE Posterior Replacement Crown - First Primary Molar Mandibular Left, Size 6 / Light Shade

NUSMILE, LTD.

Preformed dental crown, temporary
Primary Device ID00810118106989
NIH Device Record Key11bb5610-c44c-454d-a0be-1e592008b07c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNuSmile ReVIVE Crowns
Version Model NumberDLL6706L
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100810118106989 [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 Date2025-12-04
Device Publish Date2025-11-26

On-Brand Devices [NuSmile ReVIVE Crowns]

00810118106798NuSmile ReVIVE Cuspid Replacement Crown - Cuspid, Size 1 - Universal / Light Shade
00810118106781NuSmile ReVIVE Anterior Replacement Crown - Lateral, Size 5 - Universal / Light Shade
00810118106774NuSmile ReVIVE Anterior Replacement Crown - Lateral, Size 4 - Universal / Light Shade
00810118106767NuSmile ReVIVE Anterior Replacement Crown - Lateral, Size 3 - Universal / Light Shade
00810118106750NuSmile ReVIVE Anterior Replacement Crown - Lateral, Size 2 - Universal / Light Shade
00810118106743NuSmile ReVIVE Anterior Replacement Crown - Lateral, Size 1 - Universal / Light Shade
00810118106736NuSmile ReVIVE Anterior Replacement Crown - Central, Size 5 - Universal / Light Shade
00810118106729NuSmile ReVIVE Anterior Replacement Crown - Central, Size 4 - Universal / Light Shade
00810118106712NuSmile ReVIVE Anterior Replacement Crown - Central, Size 3 - Universal / Light Shade
00810118106705NuSmile ReVIVE Anterior Replacement Crown - Central, Size 2 - Universal / Light Shade
00810118106699NuSmile ReVIVE Anterior Replacement Crown - Central, Size 1 - Universal / Light Shade
00810118106675NuSmile ReVIVE Regular First and Second Primary Molar - Starter Kit - 32 Crowns, Light Shade
00810118106668NuSmile ReVIVE Narrow First Primary Molar Crowns Starter Kit - 32 Crowns, Light Shade
00810118106835NuSmile ReVIVE Cuspid Replacement Crown - Cuspid, Size 5 - Universal / Light Shade
00810118106828NuSmile ReVIVE Cuspid Replacement Crown - Cuspid, Size 4 - Universal / Light Shade
00810118106811NuSmile ReVIVE Cuspid Replacement Crown - Cuspid, Size 3 - Universal / Light Shade
00810118106804NuSmile ReVIVE Cuspid Replacement Crown - Cuspid, Size 2 - Universal / Light Shade
00810118107856NuSmile ReVIVE Anterior Pediatric Crowns Evaluation Kit - 18 Crowns, Light Shade
00810118107849NuSmile ReVIVE Cuspid Replacement Crown - Lower Cuspid, Size 6 - Universal / Light Shade
00810118107832NuSmile ReVIVE Cuspid Replacement Crown - Lower Cuspid, Size 0 - Universal / Light Shade
00810118107825NuSmile ReVIVE Cuspid Replacement Crown - Cuspid, Size 6 - Universal / Light Shade
00810118107818NuSmile ReVIVE Cuspid Replacement Crown - Cuspid, Size 0 - Universal / Light Shade
00810118107801NuSmile ReVIVE Anterior Replacement Crown - Lateral, Size 6 - Universal / Light Shade
00810118107795NuSmile ReVIVE Anterior Replacement Crown - Lateral, Size 0 - Universal / Light Shade
00810118107788NuSmile ReVIVE Anterior Replacement Crown - Central, Size 6 - Universal / Light Shade
00810118107771NuSmile ReVIVE Anterior Replacement Crown - Central, Size 0 - Universal / Light Shade
00810118107764NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Right, Size 7
00810118107757NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Right, Size 6
00810118107740NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Right, Size 5
00810118107733NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Right, Size 4
00810118107726NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Right, Size 3
00810118107719NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Right, Size 2
00810118107702NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Right, Size 1
00810118107696NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Left, Size 7 /
00810118107689NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Left, Size 6 /
00810118107672NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Left, Size 5 /
00810118107665NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Left, Size 4 /
00810118107658NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Left, Size 3 /
00810118107641NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Left, Size 2 /
00810118107634NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Maxillary Left, Size 1 /
00810118107627NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Mandibular Right, Size 7
00810118107610NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Mandibular Right, Size 6
00810118107603NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Mandibular Right, Size 5
00810118107597NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Mandibular Right, Size 4
00810118107580NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Mandibular Right, Size 3
00810118107573NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Mandibular Right, Size 2
00810118107566NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Mandibular Right, Size 1
00810118107559NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Mandibular Left, Size 7
00810118107542NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Mandibular Left, Size 6
00810118107535NuSmile ReVIVE Narrow Posterior Replacement Crown - First Primary Molar Mandibular Left, Size 5

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.