Manufacturer registered with FDA
Steri-Shield Incorporated
Fernandina Beach, FL, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Steri-Shield Incorporated currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| X-Ray Film HolderEGZ · Class 1 | — | Maker | X-ray Film Holder | 2014 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Bracket Label Arm Cover | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Steri-Shield Incorporated lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Steri-Shield Products, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Mar 1989 | K884219 | BRACKET TABLE ARM COVER | Steri-Shield Products, Inc. | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| STERI-SHIELD INCORPORATEDFDA reg. 3011326671 | Fernandina Beach, FL, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048330). 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.