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NUSMILE, LTD

US

Last updated September 17, 2026

Information

Country
US
Address
3315 W 12th St, HOUSTON, TX, 77008
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
—
FDA FEI Number
3006444232
DUNS Number
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Catalogue (1751)

Page 23 of 36
DeviceModel / ReferenceRegistriesClassStatus
NuSmile Pre-Contoured Stainless Steel Crown EUR5606HS
FDA UDI
Class IActive
NuSmile Pre-Contoured Stainless Steel Crown DLR3606
FDA UDI
Class IActive
NuSmile ZR Anterior Try-In Crown LC5L304
FDA UDI
Class IActive
NuSmile ZR Cuspid Replacement Crown LC2R204X
FDA UDI
Class IActive
NuSmile Signature Anterior Replacement Crown B5R104X
FDA UDI
Class IActive
NuSmile BioFlx Posterior Replacement Crown - First Primary Molar DLL1407L
FDA UDI
Class IActive
NuSmile Pre-Contoured Stainless Steel Crown 6LR4606HS
FDA UDI
Class IActive
Avalon Biomed NeoSEALER Flo Tips CKT20
FDA UDI
N/AUnknown
ApicalShaper sterile 31mm Z30-Z50 ZAS31ASST1
FDA UDI
Class IActive
NuSmile Signature Posterior Replacement Crown DUL4106L
FDA UDI
Class IActive
BlueShaper sterile 25mm Z5 ZBS25Z0005
FDA UDI
Class IActive
Avalon Biomed by Zarc BlueShaper PRO File 21mm (Z1-4) ZBS21APRO4
FDA UDI
Class IActive
NuSmile ZR Anterior Try-In Crown A1R304
FDA UDI
Class IActive
NuSmile ZR Posterior Replacement Crown DUL5206X
FDA UDI
Class IActive
NuSmile BioFlx Anterior Replacement Crown - Lateral B3L404L
FDA UDI
Class IUnknown
NeoLINER LC 1 g Kit (Canada) NNLCSK
FDA UDI
N/AActive
NuSmile Pre-Contoured Stainless Steel Crown DUR4606HS
FDA UDI
Class IActive
NuSmile BioFlx Posterior Replacement Crown - Second Primary Molar ELR3406L
FDA UDI
Class IActive
NuSmile Signature Anterior Replacement Crown B5L105LS
FDA UDI
Class IActive
NuSmile BioFlx Posterior Replacement Crown - First Primary Molar DUL3407L
FDA UDI
Class IActive
NuSmile ZR Permanent Molar Try-In Crown Y6LR5350
FDA UDI
Class IActive
NuSmile ZR Narrow Posterior Replacement Crown ELR4207L
FDA UDI
Class IActive
NuSmile ZR Anterior Try-In Crown U2304
FDA UDI
Class IActive
NuSmile BioFlx Posterior Replacement Crown - Second Primary Molar EUL5406L
FDA UDI
Class IActive
NuSmile Signature Anterior Replacement Crown A2R104L
FDA UDI
Class IActive
K Flex 25mm 20 ZKFLEX2520
FDA UDI
Class IActive
Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1) ZSS210PRO1
FDA UDI
Class IActive
Z-Glider sterile files 21mm ZZG000021
FDA UDI
Class IActive
NuSmile BioFlx Anterior Central and Lateral - Mini Kit MN404C
FDA UDI
Class IActive
NuSmile BioFlx Permanent Molar Replacement Crown Y6UR3450L
FDA UDI
Class IActive
NuSmile ZR Posterior Try-In Crown DLR2306
FDA UDI
Class IActive
NuSmile ZR Posterior Replacement Crown ELL4206X
FDA UDI
Class IActive
NuSmile ZR Narrow Posterior Try-In Crown DUR4307
FDA UDI
Class IActive
NuSmile Signature Cuspid Replacement Crown C2104X
FDA UDI
Class IActive
NuSmile ZR Narrow Posterior Replacement Crown DUR6207L
FDA UDI
Class IActive
NuSmile Signature Posterior Pediatric Mini Kit "D" Crowns MND106X
FDA UDI
Class IActive
K File 21mm 10 ZKFILE2110
FDA UDI
Class IActive
K Flex 25mm 15 ZKFLEX2515
FDA UDI
Class IActive
NuSmile BioFlx Posterior Replacement Crown - First Primary Molar DUL2407L
FDA UDI
Class IActive
NuSmile Signature Anterior Pediatric Crowns Starter Kit SK104L
FDA UDI
Class IActive
NuSmile ZR Posterior Try-In Crown EUR2306
FDA UDI
Class IActive
K Flex 25mm 30 ZKFLEX2530
FDA UDI
Class IActive
NuSmile Signature Anterior Pediatric Crowns Evaluation Kit EK105LS
FDA UDI
Class IActive
NuSmile ZR Cuspid Replacement Crown C3R204L
FDA UDI
Class IActive
NuSmile BioCem Medium Shade BCK450MD
FDA UDI
Class IIUnknown
NuSmile Signature Cuspid Replacement Crown LC5105LS
FDA UDI
Class IActive
Excalibur sterile 31mm E20-E45 ZRE31ASST1
FDA UDI
Class IActive
Z-Plugger 40/80 UDPL408001
FDA UDI
Class IActive
BlueShaper sterile 25mm Z6 ZBS25Z0006
FDA UDI
Class IActive
K File 21mm 25 ZKFILE2125
FDA UDI
Class IActive

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