Dentis OneQ-SL
Also known as: OneQ-SL
A tapered bone-level implant from Dentis with a coronal-to-apical diameter taper and an SLA surface.
Quick facts
| Manufacturer | Dentis Co., Ltd.Verified spec[1] |
|---|---|
| Implant level | Bone-levelVerified spec[1] |
| Body geometry | Tapered fixture in which the coronal (platform) diameter is wider than the apical diameter — e.g. Ø3.7 coronal narrows to Ø3.55 apicalVerified spec[1] |
| Material | Grade-4 commercially pure titaniumVerified spec[1] |
| Surface | SLA — sandblasted with large grit and acid-etchedVerified spec[1] |
| Connection | Manufacturer documentation not located(The FDA summary lists dimensions but does not state the internal connection geometry.) |
| Available diameters | Coronal platform diameters Ø3.7, 4.2, 4.7, 5.2, 6.0 and 7.0 mmVerified spec[1] |
| Available lengths | 7, 8, 10, 12 and 14 mmVerified spec[1] |
Overview
Technology
Further detail
| Country | South KoreaVerified spec[1] |
|---|
Clinical evidence
We have not yet completed a system-specific evidence review for Dentis OneQ-SL. Insufficient system-specific evidence How we grade evidence
Similar implant systems
The clearances below are held by Dentis at brand level and cover its implant range, not Dentis OneQ-SL specifically. We show them here because that is the level at which regulators actually issue them.
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) clearance27 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 |
| K222913 | s-Clean Link Abutment | Dentis Co., Ltd. | 2023-01-13 |
| 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 |
| K150344 | Dentis Dental Implant System | Dentis Co., Ltd. | 2015-07-24 |
| K082843 | MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM | Dentis Co., Ltd. | 2009-06-19 |
| K073486 | DENTIS DENTAL IMPLANT SYSTEM | Dentis Co., Ltd. | 2008-04-04 |
Other1 record
Of 100 records we inspected, 100 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (100). 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) K142313 — OneQ-SL Implant System — U.S. Food & Drug Administration, 2015. Accessed 2026-07-21.