Manufacturer registered with FDA
Changzhou IVORIE Shengmei Packaging Technology Co.Ltd
Changzhou, China. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 20
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Changzhou IVORIE Shengmei Packaging 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 | HEAT SOURCE FOR BLEACHING TEETH (Teeth Whitening Mini Light; Mini Light 1led/5led;Smart Teeth Whitening Light; Teeth Whitening Lamp)Teeth whitening Led Light 8led/16ledSmart Teeth Whitening Device;Teeth whitening Led Light(MD666); Teeth Whitening Mouth Tray Led Light;Teeth Whitening Light 8led/16led; Teeth Whitening Accelerator; Plusma Light; Teeth Whitening Light;Teeth Whitening Mouth Tray Light; Portable Teeth Whitening Light; | 2018 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Lister | Water flosser/Oral Irrigator | 2021 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Denture Cleansing Tablet | 2018 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Teeth Wipes,Brush Ups,Finger Brush,Oral Brush Ups | 2018 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Foam Strip Mouth Tray/Gel Prefilled Mouth Tray/ Bruxism mouth guardThermoplastic Mouth Tray/Mouth Piece/Sports mouth guard/Teeth Whitening Mouth Tray | 2018 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel | 2018 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek Retractor/Mouth Opener/Lip Retractor | 2018 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | Electric Toothbrush, Sonic Toothbrush, Electric Led Toothbrush, Sonic Led Toothbrush | 2018 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Coconut oil pulling; Coconut oil sachet, Oral care kit, ToothpasteDouble Elastic Gel Strips/Dry Strips/Dissolving Strip; teeth whitening powder; charcoal teeth whitening powderPROFESSIONAL WHITENING GEL; Remineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home KitTeeth Bleaching System/Teeth Bleaching Kit/Teeth Whitening StripsTeeth Whitening Pen/Empty Pen/Bleaching Pen/Teeth Whitener/Teeth Whitening Gel 3ml/5ml/10mlTeeth Whitening System; Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syring Gel, Double Barrel Syringe Gel; | 2018 |
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 |
|---|---|---|
| Changzhou IVORIE Shengmei Packaging Technology Co.LtdFDA reg. 3014314529 | Changzhou Jiangsu, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056830). 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.