# Hismile PTY Ltd (foreign exporter, BURLEIGH WATERS Queensland, AU): 1 new FDA device listing, incl. cleanser, denture, over the counter

**Score:** 35/100

| Field | Value |
|---|---|
| Establishment | Hismile PTY Ltd |
| Owner / operator | HiSmile Pty Ltd |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device; Foreign Private Label Distributor |
| Location | BURLEIGH WATERS Queensland, AU |
| New listings | 1 |
| Devices | Cleanser, Denture, Over The Counter |
| Product codes | EFT |
| Device classes | Class I |
| Medical specialties | Dental |
| Brand names | Hismile Germ Warfare Dental Appliance Cleaning Powder |
| First new listing | 2026-09-23 |
| Latest new listing | 2026-09-23 |
| FDA registration number | 3014610038 |
| Registration expires | 2027-12-31 |

## Why this score
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.