Registered with FDA
Boss Instruments Ltd
Gordonsville, VA, United States. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 7331 registrations outside the US
- Establishments
- 1United States
Registered in 7 markets
Where regulators' registries name Boss Instruments 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 | Lister | Boss Instruments Ltd | 12 device types | — | Below |
| South Korea | MFDS | Manufacturer | Boss Instruments Ltd., Inc.BOSS Instruments,Ltd. · BOSS Instruments, Ltd. · +2 | 150 | 2001–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | BOSS INSTRUMENTS, LTD. | 104 | 1999–2015 | Pure Global AI |
| Australia | TGA | Manufacturer | Boss Instruments Ltd | 39 | 2007–2025 | Pure Global AI |
| Colombia | INVIMA | Registration holder | BOSS INSTRUMENTS LTD | 20 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BOSS INSTRUMENTS, LTD.BOSS INSTRUMENTS, INC. | 13 | 2005–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BOSS INSTRUMENTS LTD | 5 | 2012–2014 | 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 Boss Instruments 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 | Lister | — | 2019 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Boss Mirror | 2019 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | Boss Dental Retractors | 2019 |
| Endodontic CuretteEKT · Class 1 | Dental hand instruments | Lister | Endodontic Curette | 2014 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Lister | BOSS | 2008 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Lister | — | 2019 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Lister | dental rongeur | 2014 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Lister | — | 2019 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | — | 2019 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Lister | — | 2019 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Lister | bone chisel | 2014 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Lister | — | 2019 |
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 |
|---|---|---|
| BOSS INSTRUMENTS, LTD.FDA reg. 1056350 | Gordonsville, VA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9005081). 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.