Manufacturer registered with FDA
Precision Edge Surgical Products Company
Sault Sainte Marie, MI, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 9
- 510(k) clearances
- 0as applicant
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1United States
Registered in 3 markets
Where regulators' registries name Precision Edge Surgical Products Company 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 | Precision Edge Surgical Products Company | 2 device types | — | Below |
| Colombia | INVIMA | Manufacturer | PRECISION EDGE SURGICAL PRODUCTS COMPANY | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Precision Edge Surgical Products Company | 1 | 2024–2024 | 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 Precision Edge Surgical Products Company currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | COUNTERSINK W/CENTERING PINS FOR 2.4MM SCREWS/HEX COUPLINGCOUNTERSINK W/CENTERING PINS FOR 2MM SCREWS/HEX COUPLING | 2024 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | MICRO BUR 0.35MMMICRO BUR 0.5MMMICRO BUR 0.85MMMICRO BUR 1.45MMMICRO BUR 3.85MMSIDE CUT DRUM 6.1x3.8MM, MED1.45MM BUR 7FLUTES | 2012 |
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 |
|---|---|---|
| PRECISION EDGE SURGICAL PRODUCTS COMPANYFDA reg. 1833986 | Sault Sainte Marie, MI, United States | Contract manufacturer, Manufacturer for export |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042577). 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.