Manufacturer registered with FDA
NuSmile, Ltd.
Houston, TX, United States. Lists 18 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 18
- Brands and models
- 91
- 510(k) clearances
- 22019–2026
- Markets registered in
- 15162 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 15 markets
Where regulators' registries name NuSmile, Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | NuSmile, Ltd. | 2 clearances | 2019–2026 | Below |
| Canada | Health Canada | Registration holder | NUSMILE, LTD. | 100 | 2010–2022 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | NUSMILE LTD | 19 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | NUSMILE LTD | 8 | 2020–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | NuSmile, LtdNUSMILE, LTD | 7 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | NuSmile, LTD | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | NUSMILE, LTD.NuSmile, Ltd · NuSmile Ltd | 5 | 2013–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | NuSmile | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | NuSmile Ltd | 3 | 2013–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | NUSMILE, LTDNUSMILE Ltd. | 3 | 2020–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | NuSmile, Ltd. | 2 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | NuSmile Ltd | 2 | 2025–2025 | Pure Global AI |
| China | NMPA | Registration holder | 纽思迈有限责任公司NuSmile.Ltd | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | NUSMILE, LTD | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | NuSmile,Ltd | 1 | 2016–2016 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What NuSmile, Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | Avalon Biomed Grey MTA PlusAvalon Biomed NeoMTA 2Avalon Biomed NeoMTA PlusAvalon Biomed NeoPUTTYAvalon Biomed NeoSEALER EZFloAvalon Biomed NeoSEALER FloMTA 2.3.1NuSmile NeoMTANuSmile NeoMTA 2NuSmile NeoMTA ES 3 moreNuSmile NeoPEXNuSmile NeoPUTTYZarc NeoMTA 2 Bioceramic Reparative Cement by Avalon Biomed | 2015 |
| Calcium Hydroxide Cavity LinerEJK · Class 2 | — | Maker | NeoLINERNuSmile BioCemNuSmile NeoPEX | 2014 |
| Dental CementEMA · Class 2 | Dental cements | Maker | NuSmile BioCemNuSmile NuCem | 2014 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Lister | NuSmile NuNamel Varnish | 2025 |
| Diammine Silver Fluoride Dental Hypersensitivity VarnishPHR · Class 2 | — | Lister | Avalon Biomed Silver Diamine Fluoride (SDF)NuSmile NuNamel Silver Diamine Fluoride (SDF)NuSmile Silver Diamine Fluoride (SDF) | 2024 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Chairside Space Maintainer | 2022 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | NuSmile Bite Stick / Band Seater - WhiteNuSmile Heavy Band PusherNuSmile Posterior Band Remover | 2026 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Lister | NuSmile NuNamel Sealant | 2025 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Lister | NuSmile Heavy Curved Scissors | 2026 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | Avalon Biomed Basic Flex TipsAvalon Biomed Clear Flex TipsAvalon Biomed Navi TIpsAvalon Biomed NeoSEALER EZFlo 29-gauge Dispensing TipsAvalon Biomed NeoSEALER Flex Flo TipsAvalon Biomed NeoSEALER Flo Basic Flex TipsAvalon Biomed NeoSEALER Flo tipsNuSmile NuNamel Brush TipsZ-Rinse | 2020 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Lister | Endo-Block RulerFile Organizer, Autoclavable RulerZ-Guage RulerZ-Ruler | 2025 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | ApicalShaper Gutta-PerchaBlueShaper Gutta-PerchaExcalibur Gutta-PerchaExcalibur Mini Gutta-PerchaNanoShaper Gutta-PerchaSlimShaper Gutta-PerchaZ-Fit Gutta-PerchaZarc Fine Gutta-PerchaZarc Gutta-PerchaZarc X-Fine Gutta-Percha | 2025 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | ApicalShaper Paper PointBlueShaper Paper PointExcalibur Mini Paper PointExcalibur Paper PointNanoShaper Paper PointSlimShaper Paper PointZ-Fit Paper PointZarc Fine Paper PointZarc Paper PointZarc X-Fine Paper Point | 2025 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | Z Micro-OpenerZ Micro-ShaperZ-DOWN SystemZ-UP System | 2025 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | ApicalShaper FileBlueShaper FileBlueShaper PRO FIleExcalibur FileExcalibur Glider PRO FileExcalibur PRO Mini FileNanoShaper FileRetreatAll FileSlimShaper FileSlimShaper PRO File 4 moreZ-Condensor FileZ-Glider Evo FileZ-Glider FileZ-Plugger | 2025 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | Avalon Biomed by ZARC Z-Evo | 2022 |
| Preformed CrownELZ · Class 1 | — | Maker | NuSmile BioFlx CrownsNuSmile Pediatric CrownsNuSmile Pre-Contoured Stainless Steel Crowns (SSC)NuSmile ReVIVE CrownsNuSmile Signature CrownsNuSmile Zirconia (ZR) Crowns | 2007 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | NuSmile 3 Jaw PlierNuSmile Band / Crown Crimping PlierNuSmile Bird Beak PlierNuSmile Contouring PlierNuSmile Tube Crimping Plier | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names NuSmile, Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Sep 2026 | K253909 | NeoPEX Pre-Mixed Obturation Paste | KIF Root Canal Filling Resin |
| 11 Jan 2019 | K181917 | MTA2.3 MATERIALS | KIF Root Canal Filling Resin |
Some of these clearances are listed with FDA today by another company: Ultradent Products, Inc. (1), Gebr. Brasseler GmbH & Co. KG (1).
Also lists devices cleared under other names
NuSmile, Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Avalon Biomed, Inc. (3), Spident Co., Ltd. (1), Kids-E-Dental LLP (1), Centrix, Inc. (1), Changzhou Sifary Medical Technology Co., Ltd. (1), S&C Polymer Silicon- Und Composite Spezialitaten GmbH (1), Ultradent Products Inc. / Oratech, LLC (1), Pulpdent Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Jun 2025 | K250566 | EsCem RMGI | Spident Co., Ltd. | EMA Dental Cement |
| 6 Mar 2024 | K240619 | e-SDF | Kids-E-Dental LLP | PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish |
| 27 Oct 2023 | K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38% | Centrix, Inc. | PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish |
| 29 Jan 2021 | K201993 | E-connect S Endo Motor with built-in Apex Locator | Changzhou Sifary Medical Technology Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 20 Nov 2020 | K202413 | LC ResinCal PC | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | EJK Calcium Hydroxide Cavity Liner |
| 1 Sep 2016 | K161239 | MTA2.2 MATERIAL | Avalon Biomed, Inc. | KIF Root Canal Filling Resin |
| 11 Jun 2014 | K140955 | MTA2.1 MATERIAL | Avalon Biomed, Inc. | KIF Root Canal Filling Resin |
| 1 Nov 2013 | K132109 | ENAMELAST | Ultradent Products Inc. / Oratech, LLC | LBH Cavity Varnish |
| 11 Dec 2012 | K122892 | MTA2 ROOT AND PULP MATERIALS | Avalon Biomed, Inc. | KIF Root Canal Filling Resin |
| 7 Dec 2012 | K123265 | RMGI LOW VISCOSITY | Pulpdent Corporation | EMA Dental Cement |
| 23 Sep 2011 | K112517 | ULTRASEAL XT HYDRO | Ultradent Products, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 4 Feb 2004 | K040098 | VARNISHAMERICA | Medical Products Laboratories, Inc. | LBH Cavity Varnish |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NUSMILE, LTDFDA reg. 3006444232 | HOUSTON, TX, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9106343). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.