Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in South KoreaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Osstem Implant and its 4 subsidiaries with 98 510(k) clearances and 10 device recalls. The most recent is a 510(k) clearance dated May 14, 2026: ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Osstem Implant and its 4 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 14, 2026 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsK253372 · NHA | 510(k) clearances |
| Mar 4, 2026 | Healing Abutment SystemK251434 · NHA | 510(k) clearances |
| Jan 29, 2026 | EK MULTI ANGLED 30 ABUTMENTK251427 · NHA | 510(k) clearances |
| Aug 26, 2025 | Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.Class II · Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this el | Device recalls |
| Aug 26, 2025 | Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.Class II · Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this el | Device recalls |
| Aug 26, 2025 | Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.Class II · Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this el | Device recalls |
| Aug 13, 2025 | Bone ScrewK251569 · DZL | 510(k) clearances |
| Jul 17, 2025 | K5 Cart, K5 Mount, K5 SwingK251491 · EIA | 510(k) clearances |
| Jan 8, 2025 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)K241003 · NHA | 510(k) clearances |
| Nov 20, 2024 | Estar-ZEK242521 · EIH | 510(k) clearances |
| Sep 13, 2024 | EK D3.3 and Ultra Wide ImplantsK240232 · DZE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
