Manufacturer registered with FDA
Gavin Biotechnology Co.,ltd
Jinzhong, China. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 23
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Gavin Biotechnology Co.,ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Gavin Biotechnology Co.,ltd | 12 device types | — | Below |
| Taiwan | TFDA | Manufacturer | GAVIN BIOTECHNOLOGY CO., LTD | 1 | 2020–2020 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Gavin Biotechnology 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dental Apex Locator | 2025 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Dental Anti-fog Mirror | 2025 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Ultrasonic Tooth Scaler | 2024 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | Dental Polishing Motor | 2024 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Maker | Utrasonic Tips ( for EMS/SATALEC/WOODPECKER/KAVO/SIRONA) | 2025 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Maker | Dental Polishing Machine | 2025 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Dental LoupeSurgical magnifying glass | 2024 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | Endodontic sealerroot canal gap-filling sealantroot canal gap-sealing pasteroot canal sealerroot canal sealing pastesealant | 2025 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Accessory Gutta Percha pointsGutta Percha points | 2023 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper PointsAccessory Absorbent Paper Points | 2023 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Dental root canal fileEndo filesHandle filesRotary files | 2022 |
| Fluid-Filled Teething RingKKO · Class 2 | — | Maker | Root canal sealer | 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 |
|---|---|---|
| GAVIN BIOTECHNOLOGY CO.,LTDFDA reg. 3025436467 | Jinzhong Shanxi, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086568). 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.