# Kj Meditech Co., Ltd. (contract manufacturer, Gwangju, KR): 2 new FDA device listings, incl. abutment, implant, dental, endosseous

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Kj Meditech Co., Ltd. |
| Owner / operator | KJ Meditech Co., Ltd. |
| Role | Contract manufacturer |
| Establishment types | Manufacture Medical Device for Another Party (Contract Manufacturer) |
| Location | Gwangju, KR |
| New listings | 2 |
| Devices | Abutment, Implant, Dental, Endosseous; Implant, Endosseous, Root-Form |
| Product codes | NHA, DZE |
| Device classes | Class II |
| Medical specialties | Dental |
| Brand names | HexaPLUS S OneDrill Implant System |
| First new listing | 2026-07-22 |
| Latest new listing | 2026-07-22 |
| FDA registration number | 3008959419 |
| Registration expires | 2026-12-31 |

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

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.