Registered with FDA
ambler surgical
Exton, PA, United States. Lists 11 dental device types with FDA across 1 registered establishment.
- Device types listed
- 11
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name ambler surgical 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 | ambler surgical | 11 device types | — | Below |
| South Korea | MFDS | Manufacturer | AMBLER SURGICALambler surgical | 3 | 2013–2024 | 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 ambler surgical 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 | Ambler | 2016 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | Ambler | 2016 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Lister | Ambler | 2016 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Lister | Ambler Surgical | 2020 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Lister | Ambler | 2016 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Lister | Ambler | 2016 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Lister | Ambler | 2016 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Lister | Ambler | 2016 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | Ambler | 2016 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Lister | Ambler | 2016 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Lister | — | 2016 |
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 |
|---|---|---|
| Ambler Surgical, LLCFDA reg. 3005528784 | EXTON, PA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9106120). 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.