Not currently registered with FDA under this name
Steri-Shield Products, Inc.
Allentown, PA, United States. Named as applicant on 5 dental 510(k) clearances between 1989 and 1989. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 51989–1989
- Markets registered in
- 32 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 3 markets
Where regulators' registries name Steri-Shield Products, 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 | Applicant | Steri-Shield Products, Inc. | 5 clearances | 1989–1989 | Below |
| Australia | TGA | Manufacturer | Steri-Shield Products | 1 | 2018–2018 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | STERI-SHIELD PRODUCTS | 1 | 2016–2016 | 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
510(k) clearances
Clearances on which FDA names Steri-Shield Products, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 Mar 1989 | K884223 | DENTAL LAMP HANDLE COVER | EAZ Dental Operating Light |
| 17 Mar 1989 | K884222 | CURING LIGHT COVER | EBZ Ultraviolet Activator for Polymerization |
| 17 Mar 1989 | K884221 | ULTRASONIC SCALER COVER | ELC Ultrasonic Scaler |
| 17 Mar 1989 | K884220 | AIR WATER SYRINGE TIP SHIELD | EFS Oral Irrigation Unit |
| 17 Mar 1989 | K884219 | BRACKET TABLE ARM COVER | EIA Operative Dental Unit |
Some of these clearances are listed with FDA today by another company: Steri-Shield Incorporated (1).
Sources
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 of the most recent filing, which can be a US agent.