Manufacturer registered with FDA
Armor Dental Corporation
Hingham, MA, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 18
- 510(k) clearances
- 0as applicant
- Markets registered in
- 55 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name Armor Dental Corporation 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 | Armor Dental Corporation | 3 device types | — | Below |
| Australia | TGA | Manufacturer | Armor Dental Corp | 2 | 2025–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Armor Dental Corp | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Armor Dental Corp | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ARMOR DENTAL CORPORATION | 1 | 2019–2019 | 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 Armor Dental Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | MirroSoft Delta MirrorMirroSoft No. 4 MirrorMirroSoft No. 5 Double MirrorMirroSoft No. 5 MirrorMirroSoft TearDrop Mirror | 2025 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Scan-Mate® (Black)Scan-Mate® (Blue)Scan-Mate® MegaGenTissuePro Distal Sleeve, MN RetractorTissuePro Distal Sleeve, MN Retractor Single-UseTissuePro Proximal Sleeve, MN RetractorTissuePro Single Sleeve, MN Retractor | 2019 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Comfort Soft LargeComfort Soft SmallMouth Mate®Tongue-Guide Infant HomeTongue-Guide Infant ProTongue-Guide Standard Pro | 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 |
|---|---|---|
| ARMOR DENTAL CORPFDA reg. 3012990641 | Hingham, MA, United States | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10052711). 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.