Hubei Guarddent Medical Technology Co.,Ltd (manufacturer, Wuhan Hubei, CN): 10 new FDA device listings, incl. pusher, band, orthodontic
Hubei Guarddent Medical Technology Co.,Ltd (Wuhan Hubei): 10 new FDA device listings, incl. pusher, band, orthodontic. Its amount of 10 is top-decile (93rd percentile of 2,570 records). Dated 105 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-10-28, 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: 10 · 93th percentile of 2,570 DeviceEstablishmentPulse records · 10.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 499 related CN DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Hubei Guarddent Medical Technology Co.,Ltd |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Export Device to the United States But Perform No Other Operation on Device |
| Location | Wuhan Hubei, CN |
| New listings | 10 |
| Devices | Pusher, Band, Orthodontic; Dental Barriers And Sleeves; Mixer, Cement, For Clinical Use; Cleaner, Denture, Mechanical; Instrument, Manual, Surgical, General Use; Unit, Operative Dental, Accessories; Syringe, Irrigating (Dental); Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear); Handle, Scalpel; Tape, Measuring, Rulers And Calipers |
| Product codes | ECS, PEM, JDZ, JER, MDM, NRD, EIB, HOY, GDZ, FTY |
| Device classes | Class I, Class II |
| Medical specialties | Dental, General, Plastic Surgery, Orthopedic, Ophthalmic |
| Brand names | Aligner Chewies; Dental Barrier and Sleeves; Dental Mixing Bowl/Mixing Wells; Retainer Storage Case/Retainer Box/Denture Box; Instrument Disinfection Box; Dappen Dish/Mixing Spatulas; Curved Syringe; Safety Glasses |
| First new listing | 2026-05-19 |
| Latest new listing | 2026-07-23 |
| FDA registration number | 3017910185 |
| Registration expires | 2026-12-31 |
| amount percentile | 93th of 2,570 (median 1, 10.0x median) |
| Peer records CSV (500 CN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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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: 2026-07-23
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Hubei Guarddent Medical Technology Co.,Ltd and 687 CN peers
- CN DeviceEstablishmentPulse records like this one: 687
- Hubei Guarddent Medical Technology Co.,Ltd's amount: 93rd percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every CN peer: $137,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
75 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Hubei Guarddent Medical Technology Co.,Ltd in Wuhan Hubei?
Hubei Guarddent Medical Technology Co.,Ltd (Wuhan Hubei, CN), a manufacturer, added 10 FDA device listings between 2026-05-19 and 2026-07-23.
How does Hubei Guarddent Medical Technology Co.,Ltd compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 10 is 10.0x the median of 1 across 2,570 records. It is 105 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.
Hubei Guarddent Medical Technology Co.,Ltd vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Hubei Guarddent Medical Technology Co.,Ltd | Wuhan Hubei, CN | 10 | 93rd | 2026-07-23 |
| Boston Scientific Corporation | Coventry, RI | 10 | 93rd | 2026-10-16 |
| Paragon 28 | Englewood, CO | 9 | 92nd | 2026-10-08 |
| Abyrx, Inc. | Stamford, CT | 7 | 90th | 2026-10-07 |
Related records
DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: Foreign establishment
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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.