Manufacturer registered with FDA
Jiangxi IVISMILE Technology Co.,Ltd
Yichun City, China. Lists 13 dental device types with FDA across 1 registered establishment.
- Device types listed
- 13
- Brands and models
- 46
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Jiangxi IVISMILE Technology Co.,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 |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | Mini Light 1led/5led;Teeth Whitening Light 8led/16led/32led;Teeth Whitening Led Light 8led/16led/32led;Plusma Light; Moons, Moonlight; Pola LED mouthpiece; ProLite LED Teeth Whitening Device; Smart Teeth Whitening Light;Teeth Whitening Lamp; Teeth Whitening Accelerator; Teeth Whitening Mini Light; Teeth Whitening Light;Teeth Whitening Led Light; Portable Teeth Whitening Light; Smart Teeth Whitening Device;Teeth Whitening Mouth Tray Led Light; Teeth Whitening Mouth Tray Light; Wireless Mouthpiece Led Light,Wireless Teeth Whitening Device; UNICSKIN White Smile 5 | 2024 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Water flosser; Be Lucent Pulse water flosser | 2024 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Denture Cleansing Tablet | 2024 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Finger Brush; Oral Brush Ups; Teeth Wipes; Brush Ups; Toothbrush, Bamboo Toothbrush | 2024 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Foam Strip Mouth Tray; Gel Prefilled Mouth Tray; Thermoplastic Mouth Tray; Mouth Piece; Teeth Whitening Mouth Tray | 2024 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Dental Dam; Dental Gum Dam; Gum Protector Gel; Gingival Protection Gel | 2024 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek Retractor; Mouth Opener; Lip Retractor | 2024 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Dental Teeth Cleaner | 2024 |
| Gingival Fluid MeasurerJEO · Class 1 | — | Maker | IntelliWHiTE sonic toothbrush,IntelliWHiTE electric toothbrush, IntelliWHiTE brush head | 2025 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Be Lucent Spark Sonic Toothbrushreplacement toothbrush head; toothbrush head; refill toothbrush head; single refill toothbrush headSonic Toothbrush; Electric Led Toothbrush; Sonic Led Toothbrush; IVISMILE electric toothbrush;2pack toothbrush head; toothbrush head refills; toothbrush heads; Max whitening gel; Electric Toothbrush; | 2024 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Dental floss | 2024 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Aroamas Teeth Whitening Pen 3 Pack; Aroamas TEETH WHITENING KIT; AsaVea Teeth Whitening Pen (2 Pack);AsaVea Premium Teeth Whitening Kit, LED Light; Dry Strips; Dissolving Strip; Teeth Whitening Pen; Bleaching Pen;BANANA WHITE Teeth Whitening Gel; BANANA WHITE Teeth Whitening Kit; Coconut Oil Sachet;Be Lucent Glow teeth whitening strips; White&Go Purple Teeth Whitening Strip; Smile Genius Purple Teeth Whitening Strip;BOKA teeth whitening strips; Professional Whitening Gel; Dual Barrel Gel; Double Barrel Gel;CLARTE Teeth Whitening Kit; Premium Teeth Whitening System - LED Light; Teeth Whitening System;Dr Js Pearle Teeth whitening kit; Polar MD Teeth Whitening Kit; Whiter Image Teeth Whitening Led Light;ECLA Bionic Teeth Whitening Kit (35% CP); ECLA VIO54 Teeth Whitening Kit (35% CP);ECLA Mini Teeth Whitening Kit (35% CP); UNICWHITE SMILE GELECLA Purple Corrector; OLLM Teeth Whitening Kit; IBTISAMATI Teeth Whitening Kit; 16 moregemzeez teeth whitening strips; IVISMILE teeth whitening kit; IVISMILE teeth whitening gel;IntelliWHiTE blue light brush head; SmileFam Snow Serum Whitening Pen; SmileFam BLU Whitening KitIVISMILE Teeth Strengthening Strip; IntelliWHiTE BLUE32 LED Teeth Whitening Light SystemIVISMILE teeth whitening foam; IVISMILE charcoal powder; IVISMILE teeth whitening powder; ivismile teeth whitening kit,IVISMILE teeth whitening pen; IVISMILE teeth whitening strips; IVISMILE teeth whitening light;IVISMILE whitening foam; Just Smile Teeth Whitening Kit, Smilewhite Teeth Whitening Kit; Max whitening gel;Maximum Strength Serum; Teeth Whitening Wands; MONASMILE Teeth Whitening Kit YF-TWK-003; Smilex teeth whitening kit;REAL WHITE Teeth Whitening Kit; REAL WHITE Teeth Whitening Gel; Primal Life Teeth Whitening Kit;Remineralization Gel; Desensitizing Gel; Teeth Whitening Kit; Teeth Whitening Home Kit; Desensitizing Serum;Teeth Bleaching Kit; Teeth Whitening Strips; Double Elastic Gel Strips; ECLA Teeth Whitening Strips;Teeth Bleaching System; Primal Life teeth whitening gel; BOKA teeth whitening kit; BOKA teeth whitening Gel;Teeth Whitener; Dual Barrel Syringe Gel; Double Barrel Syringe Gel; Teeth Whitening Powder; Coconut Oil Pulling;Teeth Whitening Foam; Charcoal Teeth Whitening Strips; Teeth Whitening Gel 2ml/3ml/4ml/5ml/10ml;Teeth Whitening Pen [3 Pens]; Purple Teeth Whitening Strips; Purple Teeth Whitening Foam;Tetyana Naturals Teeth Whitening Pen (2 Pack), Max gel, LAB Teeth Whitening Gel, ALFA SMILE teeth whitening kitWhiter Image Teeth Whitening Kit; IntelliWHiTE blue light sonic toothbrush; IntelliWHiTE blue light electric toothbrush; | 2024 |
| Ultraviolet Sanitation/Sterilization (for Toothbrushes) Unit Non-SterileNOB · Class 1 | — | Maker | Toothbrush Sanitizer and Holder | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| JIANGXI IVISMILE TECHNOLOGY CO.,LTDFDA reg. 3030795695 | Yichun City Jiangxi, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091608). 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.