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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
—
EUDAMED SRN
—
FDA FEI Number
3006444232
DUNS Number
—

Catalogue (1751)

Page 4 of 36
DeviceModel / ReferenceRegistriesClassStatus
NuSmile BioFlx Anterior Replacement Crown - Central A0R404L
FDA UDI
Class IUnknown
Excalibur sterile 21mm E45 ZRE2104505
FDA UDI
Class IActive
NuSmile Signature Anterior Replacement Crown B1104X
FDA UDI
Class IActive
NuSmile ZR Anterior Replacement Crown A0R204L
FDA UDI
Class IActive
NuSmile Signature Anterior Replacement Crown B5R105XS
FDA UDI
Class IActive
K File 21mm 08 ZKFILE2108
FDA UDI
Class IActive
Dentsply ProRoot BioSealer 2.2 g Kit, 20 Basic Flex Tips 60620140
FDA UDI
N/AActive
NuSmile ZR Posterior Replacement Crown EUL3206L
FDA UDI
Class IActive
Avalon Biomed by Zarc BlueShaper PRO File 31mm (Z4) ZBS31ZPRO4
FDA UDI
Class IActive
NuSmile BioFlx Posterior Replacement Crown - First Primary Molar DUR4407L
FDA UDI
Class IActive
NuSmile BioFlx Anterior Replacement Crown - Lateral B2L404L
FDA UDI
Class IUnknown
NuSmile Signature Anterior Replacement Crown B5105LS
FDA UDI
Class IActive
NuSmile ZR Posterior Replacement Crown EUR3206X
FDA UDI
Class IActive
3D Obturation Kit 63800012K
FDA UDI
Class IActive
ApicalShaper sterile 25mm Z30-Z50 ZAS25ASST1
FDA UDI
Class IActive
NuSmile ZR Second Primary Molar Crowns Mini Kit MEKE206X
FDA UDI
Class IActive
Avalon Biomed by Zarc SlimShaper PRO File 25 mm (ZS1) ZSS250PRO1
FDA UDI
Class IActive
SlimShaper sterile 25mm ZS1-ZS3 ZSS25ASSTD
FDA UDI
Class IActive
Excalibur sterile 25mm E45 ZRE2504505
FDA UDI
Class IActive
NuSmile Signature Anterior Replacement Crown B3104X
FDA UDI
Class IActive
NuSmile ZR Cuspid Replacement Crown LC4R204L
FDA UDI
Class IActive
NuSmile Signature Anterior Replacement Crown A2R105LS
FDA UDI
Class IActive
NuSmile Pre-Countered Stainless Steel Crowns Second Primary Molar Professional K PKE606
FDA UDI
Class IActive
NuSmile BioFlx Permanent Molar Replacement Crown Y6UR2450L
FDA UDI
Class IActive
NuSmile ZR Posterior Replacement Crown DLL5206X
FDA UDI
Class IActive
NuSmile ZR Posterior Replacement Crown DUR1206X
FDA UDI
Class IActive
NuSmile ZR Posterior Replacement Crown ELL5206X
FDA UDI
Class IActive
NuSmile ZR Cuspid Pediatric Crowns Starter Kit SKC204L
FDA UDI
Class IActive
NuSmile ZR Narrow Posterior Try-In Crown DLL4307
FDA UDI
Class IActive
K File 25mm 10 ZKFILE2510
FDA UDI
Class IActive
NuSmile BioFlx Anterior Replacement Crown - Lateral B2404L
FDA UDI
Class IActive
NuSmile Signature Cuspd Replacement Crown C0104L
FDA UDI
Class IActive
NuSmile ZR Cuspid Replacement Crown LC6L204L
FDA UDI
Class IActive
NuSmile ZR Posterior Replacement Crown DLL1206X
FDA UDI
Class IActive
Avalon Biomed NeoSEALER Flo 2.2 g w/ 20 Flex Flo Tips ANSFK
FDA UDI
N/AActive
NuSmile Signature Posterior Replacement Crown ELR6106X
FDA UDI
Class IActive
NuSmile ZR Posterior Replacement Crown EUR6206X
FDA UDI
Class IActive
K File 21mm 30 ZKFILE2130
FDA UDI
Class IActive
NuSmile ZR Posterior Replacement Crown ELR1206L
FDA UDI
Class IActive
NuSmile Signature Posterior Replacement Crown ELL1106L
FDA UDI
Class IActive
Avalon Biomed by Zarc SlimShaper PRO File 21 mm (ZS1-ZS3) ZSS21APRO6
FDA UDI
Class IActive
Zarc by AB NeoPUTTY Bioceramic Reparative Cement Intro Kit 0.5 g - SAMPLE SZNP05K
FDA UDI
N/AActive
NuSmile BioFlx Permanent Molar Replacement Crown Y6LL7450L
FDA UDI
Class IActive
NuSmile ZR Narrow Posterior Replacement Crown DUR4207X
FDA UDI
Class IActive
Gutapercha Zarc .04/25 GP-48
FDA UDI
Class IActive
NuSmile Signature Posterior Replacement Crown DUR1106L
FDA UDI
Class IActive
NuSmile Signature Cuspid Replacement Crown LC1104X
FDA UDI
Class IActive
K File 25mm 30 ZKFILE2530
FDA UDI
Class IActive
SlimShaper sterile 31mm ZS1-ZS3 ZSS31ASST6
FDA UDI
Class IActive
Z-Plugger 35/70 UDPL357001
FDA UDI
Class IActive

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