Dentis
Also known as: Dentis Co., Ltd.
A South Korean dental implant manufacturer based in Daegu, known for the s-Clean SQ-SL and OneQ-SL implant lines.
Key facts
| Manufacturer | Dentis Co., Ltd.Verified spec[1] |
|---|---|
| Country | South KoreaVerified spec[1] |
| Headquarters | Daegu, South Korea (99 Seongseoseo-ro, Dalseo-gu), with a second plant in Dong-gu, DaeguVerified spec[1][2] |
| Founded | Manufacturer documentation not located(Widely reported as 2005 in trade coverage, but not stated on a source we could reach.) |
Overview
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance32 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | 2026-03-04 |
| K241063 | s-Clean ScanHealing Abutment | Dentis Co., Ltd. | 2024-07-25 |
| K240511 | Dentis s-Clean SQ-SL Fixture | Dentis Co., Ltd. | 2024-05-20 |
| K230126 | Dentis s-Clean Regular Abutment | Dentis Co., Ltd. | 2023-08-04 |
| K230307 | Dentis i-Clean System | Dentis Co., Ltd. | 2023-07-11 |
| K230246 | Dentis s-Clean SQ-SL Narrow Implant System | Dentis Co., Ltd. | 2023-05-25 |
| K230523 | s-Clean Link Abutment Narrow | Dentis Co., Ltd. | 2023-05-24 |
| K230203 | Dentis I-FIX Abutment | Dentis Co., Ltd. | 2023-05-03 |
| K222451 | SAVE GBR | Dentis Co., Ltd. | 2023-02-07 |
| K222913 | s-Clean Link Abutment | Dentis Co., Ltd. | 2023-01-13 |
| K222976 | MU System | Dentis Co., Ltd. | 2023-01-12 |
| K220440 | Dentis s-Clean Abutment Mini | Dentis Co., Ltd. | 2022-06-16 |
| K210410 | s-Clean Pre-Milled Abutment Mini | Dentis Co., Ltd. | 2021-09-10 |
| K210362 | s-Clean Pre-Milled Abutment | Dentis Co., Ltd. | 2021-08-19 |
| K210080 | Dentis s-Clean s-Line Mini | Dentis Co., Ltd. | 2021-06-04 |
| K210134 | Dentis s-Clean s-Line | Dentis Co., Ltd. | 2021-04-19 |
| K202773 | s-Clean SQ-SL Implant System Mini | Dentis Co., Ltd. | 2021-03-18 |
| K210132 | s-Clean SQ-SL Implant System Regular | Dentis Co., Ltd. | 2021-02-17 |
| K200099 | s-Clean SQ-SL Implant System Mini | Dentis Co., Ltd. | 2020-04-13 |
| K192688 | s-Clean SQ-SL Implant System Regular | Dentis Co., Ltd. | 2020-02-04 |
| K171694 | s-Clean TiN Coating Abutments | Dentis Co., Ltd. | 2017-11-29 |
| K171027 | Dentis Dental Implant System | Dentis Co., Ltd. | 2017-09-06 |
| K170220 | OneQ-SL s-Clean Implant System | Dentis Co., Ltd. | 2017-04-27 |
| K161244 | s-Clean OneQ-SL Narrow Implant System | Dentis Co., Ltd. | 2016-12-07 |
| K160213 | s-Clean Tapered II RBM Implant System | Dentis Co., Ltd. | 2016-06-21 |
| K153639 | OneQ-SL s-Clean Implant System | Dentis Co., Ltd. | 2016-04-08 |
| K142313 | OneQ-SL Implant System | Dentis Co., Ltd. | 2015-12-10 |
| K150344 | Dentis Dental Implant System | Dentis Co., Ltd. | 2015-07-24 |
| K111364 | HAPTITE COATING IMPLANT SYSTEM | Dentis Co., Ltd. | 2012-02-01 |
| K082843 | MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM | Dentis Co., Ltd. | 2009-06-19 |
| K083586 | I-FIX SYSTEM | Dentis Co., Ltd. | 2009-04-29 |
| K073486 | DENTIS DENTAL IMPLANT SYSTEM | Dentis Co., Ltd. | 2008-04-04 |
Other1 record
Of 200 records we inspected, 200 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (200). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.
| Number | Device | Holder | Date |
|---|---|---|---|
| 1279 device records | — | Dentis | — |
Clearance records for Dentis were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Dentis.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]FDA 510(k) K240511 — Dentis s-Clean SQ-SL Fixture — U.S. Food & Drug Administration, 2024. Accessed 2026-07-21.
- [2]FDA 510(k) K210132 — s-Clean SQ-SL Implant System Regular — U.S. Food & Drug Administration, 2021. Accessed 2026-07-21.