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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
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FDA FEI Number
3006444232
DUNS Number
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Catalogue (1751)

Page 6 of 36
DeviceModel / ReferenceRegistriesClassStatus
Avalon Biomed by Zarc Z-Glider EVO File 31mm (015) ZZGE00031
FDA UDI
Class IActive
NuSmile ZR Narrow Posterior Replacement Crown DUR7207X
FDA UDI
Class IActive
NuSmile ZR Posterior Replacement Crown ELR2206L
FDA UDI
Class IActive
NuSmile BioFlx Posterior Replacement Crown - First Primary Molar DUR6406L
FDA UDI
Class IActive
BlueShaper sterile 25mm ZX-Z5 ZBS25ASST6
FDA UDI
Class IActive
NuSmile Pre-Contoured Stainless Steel Crown ELR3606
FDA UDI
Class IActive
NuSmile BioFlx Regular - First and Second Primary Molar - Professional Kit PKDE406L
FDA UDI
Class IActive
NuSmile Signature Anterior Pediatric Crowns Professional Kit PK105LS
FDA UDI
Class IActive
ApicalShaper sterile 25mm Z35/03 ZAS2503503
FDA UDI
Class IActive
NuSmile BioFlx Permanent Molar Replacement Crown Y6LL5450L
FDA UDI
Class IActive
NuSmile Signature Cuspid Replacement Crown C3104L
FDA UDI
Class IActive
NuSmile Pre-Contoured Stainless Steel Crown EUR7606HS
FDA UDI
Class IActive
NuSmile Signature Anterior Replacement Crown A3L104X
FDA UDI
Class IActive
NuSmile ZR Permanent Molar Crown Y6LR6250A2
FDA UDI
Class IActive
NuSmile ZR Anterior Try-In Crown LC2R304
FDA UDI
Class IActive
Avalon Biomed by Zarc SlimShaper PRO File one of each 31 mm (ZS1, ZS2, ZS3) ZSS31APRO3
FDA UDI
Class IActive
Z Micro-Opener .04/10 UDMO1004
FDA UDI
Class IActive
Endo-Eze MTA Flow Repair Cement Gel 14465
FDA UDI
N/AActive
NuSmile Signature Anterior Replacement Crown B1R105LS
FDA UDI
Class IActive
Avalon Biomed by Zarc SlimShaper PRO File one of each 25 mm (ZS1, ZS2, ZS3) ZSS25APRO3
FDA UDI
Class IActive
NuSmile ZR Narrow Posterior Replacement Crown DLL7207L
FDA UDI
Class IActive
NuSmile BioCem BCK425XL
FDA UDI
Class IIActive
NuSmile BioFlx Permanent Molar Replacement Crown Y6LR2450L
FDA UDI
Class IActive
NuSmile Pre-Contoured Stainless Steel Crown DLL4606
FDA UDI
Class IActive
NuSmile ZR First Primary Molar Crowns Starter Kit SKD206L
FDA UDI
Class IActive
Hedstreom sterile 21mm 35 ZHEDST2135
FDA UDI
Class IActive
NuSmile NuNamel Pit & Fissure Sealant NNSSK
FDA UDI
Class IIActive
NuSmile NuNamel Varnish NNVB200
FDA UDI
Class IIActive
ApicalShaper sterile 21mm Z35/03 ZAS2103503
FDA UDI
Class IActive
Avalon Biomed NeoPUTTY Starter Kit 0.65 g ANPSK
FDA UDI
N/AUnknown
Excalibur sterile 31mm E20 ZRE3102005
FDA UDI
Class IActive
NuSmile Signature Anterior Replacement Crown B4105XS
FDA UDI
Class IActive
NuSmile UCSM Replacement Band RB23
FDA UDI
Class IActive
NuSmile NeoPUTTY Starter Kit 0.65 g NNPSK
FDA UDI
N/AUnknown
NuSmile Signature Posterior Replacement Crown DLR2106X
FDA UDI
Class IActive
NuSmile NuNamel Pit & Fissure Sealant NNSVK
FDA UDI
Class IIActive
NeoSEALER EZFlo (0.5 g Syringe + 4 Tips) Mini Kit ANSEZFM
FDA UDI
N/AActive
Avalon Biomed by Zarc Z-Fit Gutta Percha - Wide 30 GP-702
FDA UDI
Class IActive
NuSmile BioFlx Permanent Molar Replacement Crown Y6LR3450L
FDA UDI
Class IActive
Hedstreom sterile Assorted 25mm 45-80 ZHD25ASST2
FDA UDI
Class IActive
NuSmile Signature Anterior Replacement Crown A3R104L
FDA UDI
Class IActive
Avalon Biomed by Zarc SlimShaper PRO File 31 mm (ZS3) ZSS310PRO3
FDA UDI
Class IActive
NuSmile ZR Posterior Replacement Crown EUL2206X
FDA UDI
Class IActive
NuSmile ZR Posterior Replacement Crown EUL1206X
FDA UDI
Class IActive
NuSmile ZR Narrow Posterior Try-In Crown ELR5307
FDA UDI
Class IActive
SlimShaper sterile 21mm ZS3 ZSS2100003
FDA UDI
Class IActive
NuSmile Pre-Contoured Stainless Steel Crown DLR6606
FDA UDI
Class IActive
NuSmile ZR Permanent Molar Crown - Maxillary Right, Size 2 Y6UR2250A2
FDA UDI
Class IActive
P.P. ApicalShaper Z35 PP-435
FDA UDI
Class IActive
NuSmile ZR Narrow Posterior Try-In Crown EUL5307
FDA UDI
Class IActive

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