Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006444232

FEI Number

3006444232

Entity Name

NUSMILE, LTD

City/State/Country

HOUSTON, TX, US

Establishment Address

3315 W 12th St, HOUSTON, TX 77008, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NUSMILE, LTD (Owner Number: 9106343)

Owner / Operator Contact Address

3315 W. 12th, --, Houston, TX 77008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K140955

PMA Number

N/A

All Registered Proprietary Names

Avalon Biomed by ZARC Z-Evo Excalibur File BlueShaper PRO FIle NanoShaper File SlimShaper PRO File Z-Condensor File ApicalShaper File SlimShaper File BlueShaper File Excalibur Glider PRO File Excalibur PRO Mini File RetreatAll File Z-Glider File Z-Glider Evo File Z-Plugger NuSmile Pre-Contoured Stainless Steel Crowns (SSC) NuSmile Pediatric Crowns NuSmile Signature Crowns NuSmile Zirconia (ZR) Crowns NuSmile BioFlx Crowns NuSmile ReVIVE Crowns NeoLINER Avalon Biomed NeoMTA 2 NuSmile NeoMTA 2 MTA 2.3.1 NuSmile NeoMTA ES Zarc NeoMTA 2 Bioceramic Reparative Cement by Avalon Biomed NuSmile NuCem Avalon Biomed Silver Diamine Fluoride (SDF) NuSmile NuNamel Silver Diamine Fluoride (SDF) Z-Ruler File Organizer, Autoclavable Ruler Endo-Block Ruler Z-Guage Ruler NuSmile Tube Crimping Plier NuSmile Bird Beak Plier NuSmile 3 Jaw Plier NuSmile Band / Crown Crimping Plier NuSmile Contouring Plier Avalon Biomed NeoSolv NuSmile Bite Stick / Band Seater - White NuSmile Posterior Band Remover NuSmile Heavy Band Pusher NuSmile NuNamel Sealant NuSmile Hard Wire Cutter Avalon Biomed NeoPUTTY NuSmile NeoPUTTY Avalon Biomed NeoSEALER Flo Avalon Biomed NeoSEALER EZFlo Avalon Biomed NeoSEALER Flex Flo Tips Avalon Biomed NeoSEALER Flo tips Avalon Biomed NeoSEALER Flo Basic Flex Tips Avalon Biomed Basic Flex Tips Avalon Biomed Navi TIps Avalon Biomed Clear Flex Tips Z-Rinse NuSmile NuNamel Brush Tips NanoShaper Paper Point Excalibur Mini Paper Point ApicalShaper Paper Point Excalibur Paper Point Z-Fit Paper Point Zarc Paper Point SlimShaper Paper Point Zarc Fine Paper Point BlueShaper Paper Point Zarc X-Fine Paper Point NuSmile NuNamel Varnish NuSmile NeoMTA Avalon Biomed NeoMTA Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LQY	Locator, Root Apex	Unknown	Class U	N/A	2022-09-29
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2022-09-29
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2025-04-23
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2007-08-27
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2022-05-04
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2019-09-09
EMA	Cement, Dental	Dental	Class 2	872.3275	2025-12-15
PHR	Diammine Silver Fluoride Dental Hypersensitivity Varnish	Dental	Class 2	872.3260	2025-12-15
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2025-04-23
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2026-03-04
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2025-03-19
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2026-03-04
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2025-03-19
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2026-03-04
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2019-12-09
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2020-04-10
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2025-04-23
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2025-12-15
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2015-09-14

Official Correspondent

DIANE JOHNSON KRUEGER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NUSMILE, LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K941532	Bio-Probe, Inc.	BIOCALEX 6/9	1994-08-02
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2020	Inter-Med Llc	U	Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Z-0012-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Z-0013-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315
Z-0014-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 6%, QTY: 12, 3mL Pre-filled Syringes, REF 502350
Z-0015-2020	Inter-Med Llc	U	Vista Dental Products 3% Sodium Hypochlorite, 10- 3cc Pre-filled Syringes, REF 502355

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2411797	PARKELL, INC.	EDGEWOOD, NY, US
3012477813	Kerr Corporation	Pomona, CA, US
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006444232. Last updated year: 2026. Please use registration number 3006444232 when referencing this establishment in official correspondence.