# Osstem Implant Co.,Ltd. (manufacturer, Yeonsu-gu Incheon, KR): 11 new FDA device listings, incl. chair, dental, without operative unit

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Osstem Implant Co.,Ltd. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Foreign Private Label Distributor; Export Device to the United States But Perform No Other Operation on Device |
| Location | Yeonsu-gu Incheon, KR |
| New listings | 11 |
| Devices | Chair, Dental, Without Operative Unit; X-Ray, Tomography, Computed, Dental; Unit, Operative Dental; Unit, X-Ray, Intraoral; Unit, X-Ray, Extraoral With Timer; Chair, Dental, With Operative Unit |
| Product codes | NRU, OAS, EIA, EAP, EHD, KLC |
| Device classes | Class I, Class II |
| Medical specialties | Dental, Radiology |
| Brand names | K3-Chair only; T2 (T2-C, T2-CS); T2 Plus (T2-C-P, T2-CS-P); K3; S2 (digital intra-oral X-ray sensor); N1; K5; K5 Cart, K5 Mount, K5 Swing |
| First new listing | 2026-05-13 |
| Latest new listing | 2026-05-13 |
| FDA registration number | 3045816948 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

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: 2026-11-04T21:52:36.524Z.
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.