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 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Dentium with 27 510(k) clearances. The most recent is a 510(k) clearance dated Dec 14, 2023: bright CT.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Dec 14, 2023 | bright CTK231181 · OAS | 510(k) clearances |
| Feb 23, 2022 | SuperLineK213599 · DZE | 510(k) clearances |
| Apr 16, 2021 | rainbow CTK200271 · OAS | 510(k) clearances |
| Apr 16, 2021 | rainbow MCTK200270 · OAS | 510(k) clearances |
| Sep 4, 2020 | iCTmotor (WL-1)K193341 · EBW | 510(k) clearances |
| Jun 10, 2020 | Intraoral SensorK201247 · MQB | 510(k) clearances |
| Jan 23, 2020 | Healing Abutments and Cover ScrewsK192436 · NHA | 510(k) clearances |
| Nov 4, 2019 | Scan Abutments and Comfort CapsK191634 · NHA | 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
