Hismile PTY Ltd (foreign exporter, BURLEIGH WATERS Queensland, AU): 1 new FDA device listing, incl. cleanser, denture, over the counter
Hismile PTY Ltd (BURLEIGH WATERS Queensland): 1 new FDA device listing, incl. cleanser, denture, over the counter. Its amount of 1 is above the median of 2 (50th percentile). Dated 43 days ago, it serves as a historical benchmark. Score 35/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 1 · 50th percentile of 2,709 DeviceEstablishmentPulse records · 0.5x the median
Free preview: all 15 published fields of this record are shown below. Locked: 24 related AU DeviceEstablishmentPulse records and the 5-column CSV export.
| 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 |
| amount percentile | 50th of 2,709 (median 2, 0.5x median) |
| Peer records CSV (25 AU records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Hismile PTY Ltd
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Unlock Hismile PTY + all 25 AU records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-09-23
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top DeviceEstablishmentPulse records (AU first): Makar Consulting PTY Ltd (foreign exporter, Belrose New Sout · Signature Orthopaedics PTY Limited (manufacturer, Sydney New · Kico Knee Innovation Company (manufacturer, Frenchs Forest N · Precision Ai PTY Ltd (contract manufacturer, Brisbane Queens · Merit Medical Australia Pty Ltd. (foreign exporter, Braiside · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Hismile PTY Ltd and 25 AU peers
- AU DeviceEstablishmentPulse records like this one: 25
- Hismile PTY Ltd's amount: 50th percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every AU peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
35 / 100 Score
- Listed in the last 45 days.
What is the DeviceEstablishmentPulse record for Hismile PTY Ltd in BURLEIGH WATERS Queensland?
Hismile PTY Ltd (BURLEIGH WATERS Queensland, AU), a foreign exporter, added 1 FDA device listing on 2026-09-23.
How does Hismile PTY Ltd compare to other DeviceEstablishmentPulse records?
Its amount of 1 sits in the upper half (50th percentile) of 2,709 records; the median is 2. It is 43 days old, still within a typical 45-day follow-up window. Its Score of 35/100 is modest; treat it as background rather than a priority.
Hismile PTY Ltd vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Hismile PTY Ltd | BURLEIGH WATERS Queensland, AU | 1 | 50th | 2026-09-23 |
| Imperial Optical, Inc | Town Of Mount Royal, Quebec, CA | 3 | 77th | 2026-10-22 |
| Kash Sales Inc. | Richmond Hill Ontario, CA | 8 | 90th | 2026-10-16 |
| Mka Medikal Ic Ve Dis Ticaret Sanayi Limited Sirketi | Cankaya Ankara, TR | 9 | 92nd | 2026-10-17 |
Related records
DeviceEstablishmentPulse: Foreign exporter DeviceEstablishmentPulse: Foreign establishment
How to monitor Hismile PTY Ltd and peer foreign exporter records
Get new DeviceEstablishmentPulse records like Hismile PTY Ltd by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get new device listings in your specialties
DeviceEstablishmentPulse emails device establishments with new FDA listings matching your roles and states.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
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.