FDA.reportPublic FDA data

NUSMILE, LTD

Matched from indexed company URL: NUSMILE, LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30064442323006444232NUSMILE, LTD1Y2026-01-013315 W 12th St HOUSTON TX US 77008

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810118107962NuSmile Bite Stick / Band Seater - BS-001832-540-5964plara@nusmile.com
00810118107979NuSmile Heavy Band Pusher - BP-002832-540-5964plara@nusmile.com
00810118107986NuSmile 3 Jaw Plier - TJP-003832-540-5964plara@nusmile.com
00810118107993NuSmile Bird Beak Plier - BBP-004832-540-5964plara@nusmile.com
00810118108006NuSmile Band / Crown Crimping Plier - BCP-005832-540-5964plara@nusmile.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
263371157706536K992728SPRING POWERLITE 2000EBZ1999-09-29
263371088343106K250566EsCem RMGIEMA2025-06-20
263371326302929K241354Sealer SolventKJJ2024-08-27
263371026544270K240619e-SDFPHR2024-03-06
263371173109151K222459Centrix FluoroSilver Silver Diamine Fluoride 38%PHR2023-10-27
263371879924525K202413LC ResinCal PCEJK2020-11-20
263372052968555K201993E-connect S Endo Motor with built-in Apex LocatorEKX2021-01-29
263371517939385K181917MTA2.3 MATERIALSKIF2019-01-11
263371171270520K161239MTA2.2 MATERIALKIF2016-09-01
263371556158426K140955MTA2.1 MATERIALKIF2014-06-11
263371889822228K132109ENAMELASTLBH2013-11-01
263371274755982K123265RMGI LOW VISCOSITYEMA2012-12-07
263371882989530K122892MTA2 ROOT AND PULP MATERIALSKIF2012-12-11
263371360787637K112517ULTRASEAL XT HYDROEBC2011-09-23
263371029654305K040098VARNISHAMERICALBH2004-02-04
263371070929659
263371195843384
263371240251030
263371253231885
263371330776361
263371355388176
263371399341173
263371480306464
263371662900308
263371708488523
263371748028525
263372014795510
263372059955450

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KIF42019-01-11
EMA22025-06-20
PHR22024-03-06
LBH22013-11-01
KJJ12024-08-27
EKX12021-01-29
EJK12020-11-20
EBC12011-09-23
EBZ11999-09-29

PMN#

GUDID#

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