Manufacturer registered with FDA
Trinity Sterile Inc
Salisbury, MD, United States. Lists 11 dental device types with FDA across 2 registered establishments.
- Device types listed
- 11
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 22 registrations outside the US
- Establishments
- 2Pakistan, United States
Registered in 2 markets
Where regulators' registries name Trinity Sterile Inc 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 | Trinity Sterile Inc | 11 device types | — | Below |
| Canada | Health Canada | Registration holder | TRINITY STERILE | 2 | 2012–2012 | 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 Trinity Sterile Inc currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | BiopsyKit | 2002 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Plier | 1998 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | Aspirator | 2024 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Laryngeal Mirror | 2024 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | scissors | 1994 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Tray | 1998 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Dental | 2011 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Lister | Explorer | 2024 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Lister | Bone File | 2024 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | Elevator | 2024 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | Dental | 1999 |
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 |
|---|---|---|
| SOLATCH SONSFDA reg. 9680304 | SIALKOT Punjab, Pakistan | Manufacturer |
| TRINITY STERILE, INC.FDA reg. 1123010 | SALISBURY, MD, United States | Manufacturer, Repacker / relabeler |
Other names on FDA records
Solatch Sons
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9003800, 9007954). 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.