Chrysalis Intelligence · Sponsors · Dentis Co., Ltd.

Dentis Co., Ltd.

Daegu, KR · 24 510(k) clearances

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Total clearances
24
2020-02-04 → 2026-03-04
Last 12 months
1
Product codes
6
Most recent
2026-03-04
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NHA Abutment, Implant, Dental, Endosseous Class II Dental 12 2024-07-25
DZE Implant, Endosseous, Root-Form Class II Dental 8 2026-03-04
EKX Handpiece, Direct Drive, Ac-Powered Class I Dental 1 2025-03-21
KLC Chair, Dental, With Operative Unit Class I Dental 1 2024-09-06
NXC Aligner, Sequential Class II Dental 1 2024-02-22
DZL Screw, Fixation, Intraosseous Class II Dental 1 2023-03-23
Filings

All 510(k) clearances (24)

Date K-number Device Code Class Specialty
2026-03-04 K253493 Dentis SQ-SL AXEL Fixture DZE Class II Dental
2025-03-21 K241065 ChecQ (AC100) EKX Class I Dental
2024-09-06 K233921 Luvis Chair (LC700C) KLC Class I Dental
2024-07-25 K241063 s-Clean ScanHealing Abutment NHA Class II Dental
2024-05-20 K240511 Dentis s-Clean SQ-SL Fixture DZE Class II Dental
2024-02-22 K233544 MESHEET NXC Class II Dental
2023-08-04 K230126 Dentis s-Clean Regular Abutment NHA Class II Dental
2023-07-11 K230307 Dentis i-Clean System NHA Class II Dental
2023-05-25 K230246 Dentis s-Clean SQ-SL Narrow Implant System NHA Class II Dental
2023-05-24 K230523 s-Clean Link Abutment Narrow NHA Class II Dental
2023-05-03 K230203 Dentis I-FIX Abutment NHA Class II Dental
2023-03-23 K222367 SAVE GBR DZL Class II Dental
2023-02-07 K222451 SAVE GBR NHA Class II Dental
2023-01-13 K222913 s-Clean Link Abutment NHA Class II Dental
2023-01-12 K222976 MU System NHA Class II Dental
2022-06-16 K220440 Dentis s-Clean Abutment Mini NHA Class II Dental
2021-09-10 K210410 s-Clean Pre-Milled Abutment Mini NHA Class II Dental
2021-08-19 K210362 s-Clean Pre-Milled Abutment NHA Class II Dental
2021-06-04 K210080 Dentis s-Clean s-Line Mini DZE Class II Dental
2021-04-19 K210134 Dentis s-Clean s-Line DZE Class II Dental
2021-03-18 K202773 s-Clean SQ-SL Implant System Mini DZE Class II Dental
2021-02-17 K210132 s-Clean SQ-SL Implant System Regular DZE Class II Dental
2020-04-13 K200099 s-Clean SQ-SL Implant System Mini DZE Class II Dental
2020-02-04 K192688 s-Clean SQ-SL Implant System Regular DZE Class II Dental
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence