# Sterigenics U.S., LLC (contract sterilizer, Salem, NJ): 1 new FDA device listing, incl. implant, endosseous, root-form

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Sterigenics U.S., LLC |
| Owner / operator | Sotera Health LLC |
| Role | Contract sterilizer |
| Establishment types | Sterilize Medical Device for Another Party (Contract Sterilizer) |
| Location | Salem, NJ, US |
| New listings | 1 |
| Devices | Implant, Endosseous, Root-Form |
| Product codes | DZE |
| Device classes | Class II |
| Medical specialties | Dental |
| Brand names | EK NH Ultra Wide Implant; EK D3.3 NH Implant; EK SA Ultra Wide Implant; EK D3.3 SA Implant |
| First new listing | 2026-07-22 |
| Latest new listing | 2026-07-22 |
| FDA registration number | 2245590 |
| Registration expires | 2026-12-31 |

## Why this score
- Contract manufacturer or sterilizer adding work.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.