Medical Device Manufacturer · KR , Dalseo-Gu

Dentis Co., Ltd.

37 submissions · 37 cleared · Since 2008
37
Total
37
Cleared
0
Denied

Dentis Co., Ltd. — FDA 510(k) Submissions

Dentis Co., Ltd. has submitted 37 FDA 510(k) premarket notifications since 2008, of which 37 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Implant, Endosseous, Root-form, Abutment, Implant, Dental, Endosseous, Screw, Fixation, Intraosseous, Aligner, Sequential, Chair, Dental, With Operative Unit . Use the specialty filter in the sidebar to narrow results.

37 devices
1–25 of 37
Dentis SQ-SL AXEL Fixture
K253493 · DZE Implant, Endosseous,... · Dental
Mar 2026 128d
ChecQ (AC100)
K241065 · EKX Handpiece, Direct Drive,... · Dental
Mar 2025 337d
Luvis Chair (LC700C)
K233921 · KLC Chair, Dental, With... · Dental
Sep 2024 268d
s-Clean ScanHealing Abutment
K241063 · NHA Abutment, Implant,... · Dental
Jul 2024 98d
Dentis s-Clean SQ-SL Fixture
K240511 · DZE Implant, Endosseous,... · Dental
May 2024 88d
MESHEET
K233544 · NXC Aligner, Sequential · Dental
Feb 2024 111d
Dentis s-Clean Regular Abutment
K230126 · NHA Abutment, Implant,... · Dental
Aug 2023 199d
Dentis i-Clean System
K230307 · NHA Abutment, Implant,... · Dental
Jul 2023 158d
Dentis s-Clean SQ-SL Narrow Implant System
K230246 · NHA Abutment, Implant,... · Dental
May 2023 115d
s-Clean Link Abutment Narrow
K230523 · NHA Abutment, Implant,... · Dental
May 2023 86d
Dentis I-FIX Abutment
K230203 · NHA Abutment, Implant,... · Dental
May 2023 98d
SAVE GBR
K222367 · DZL Screw, Fixation,... · Dental
Mar 2023 230d
SAVE GBR
K222451 · NHA Abutment, Implant,... · Dental
Feb 2023 176d
s-Clean Link Abutment
K222913 · NHA Abutment, Implant,... · Dental
Jan 2023 109d
MU System
K222976 · NHA Abutment, Implant,... · Dental
Jan 2023 106d
Dentis s-Clean Abutment Mini
K220440 · NHA Abutment, Implant,... · Dental
Jun 2022 120d
s-Clean Pre-Milled Abutment Mini
K210410 · NHA Abutment, Implant,... · Dental
Sep 2021 211d
s-Clean Pre-Milled Abutment
K210362 · NHA Abutment, Implant,... · Dental
Aug 2021 192d
Dentis s-Clean s-Line Mini
K210080 · DZE Implant, Endosseous,... · Dental
Jun 2021 143d
Dentis s-Clean s-Line
K210134 · DZE Implant, Endosseous,... · Dental
Apr 2021 90d
s-Clean SQ-SL Implant System Mini
K202773 · DZE Implant, Endosseous,... · Dental
Mar 2021 178d
s-Clean SQ-SL Implant System Regular
K210132 · DZE Implant, Endosseous,... · Dental
Feb 2021 29d
s-Clean SQ-SL Implant System Mini
K200099 · DZE Implant, Endosseous,... · Dental
Apr 2020 88d
s-Clean SQ-SL Implant System Regular
K192688 · DZE Implant, Endosseous,... · Dental
Feb 2020 131d
Resin for Temporary Crown & Bridge
K180657 · EBG Crown And Bridge,... · Dental
Dec 2018 269d
Filters
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