Data / Medical devices / South Korea / Dentis Co., Ltd.

Dentis Co., Ltd.: FDA-registered device maker in Daegu, South Korea, 36 510(k) clearances

Name: Dentis Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dentis Co., Ltd. is registered with the FDA (registration 3007031098) in Daegu, South Korea. It lists 9 device types. The FDA files 36 510(k) clearances under its listings, the newest dated March 4, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3007031098
Address: 99, Seongseoseo-ro, Dalseo-Gu, Daegu, South Korea, 42718
Owner or operator: Dentis Co., Ltd. (10025697)
Roles: Exporter to the US, Manufacturer
First device listed: April 30, 2008
Registered through: 2027
Brand names listed: AXEL AOX KIT (DSAAONK, DSAAOMK), Aqua Tip (DSSAT, DSSAT31, DSSAT41), BMS Chisel (DSCL-05), BONE PROFILER KIT (DBPK), Bone Chip (DGBC50), Bone Profiler (DBP45, DBP55, DBP65), Bone Profiler Base (DBPBM, DBPBR, DBPBN), Bone Ridge Chisel (DBCA15, DBCA25) and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Accessories, Retractor, Dental	EIF	1	Manufacturer	accessdata.fda.gov
Aligner, Sequential	NXC	2	Manufacturer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Manufacturer	accessdata.fda.gov
Drill, Bone, Powered	DZI	2	Exporter to the US	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Screw, Fixation, Intraosseous	DZL	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 4, 2026	K253493	Dentis SQ-SL AXEL Fixture	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
July 25, 2024	K241063	s-Clean ScanHealing Abutment	NHA	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
May 20, 2024	K240511	Dentis s-Clean SQ-SL Fixture	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
February 22, 2024	K233544	MESHEET	NXC	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
August 4, 2023	K230126	Dentis s-Clean Regular Abutment	NHA	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
July 11, 2023	K230307	Dentis i-Clean System	NHA	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
May 25, 2023	K230246	Dentis s-Clean SQ-SL Narrow Implant System	NHA	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
May 24, 2023	K230523	s-Clean Link Abutment Narrow	NHA	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
May 3, 2023	K230203	Dentis I-FIX Abutment	NHA	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
March 23, 2023	K222367	SAVE GBR	DZL	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
February 7, 2023	K222451	SAVE GBR	NHA	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
January 13, 2023	K222913	s-Clean Link Abutment	NHA	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
January 12, 2023	K222976	MU System	NHA	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
June 16, 2022	K220440	Dentis s-Clean Abutment Mini	NHA	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
September 10, 2021	K210410	s-Clean Pre-Milled Abutment Mini	NHA	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
August 19, 2021	K210362	s-Clean Pre-Milled Abutment	NHA	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
June 4, 2021	K210080	Dentis s-Clean s-Line Mini	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
April 19, 2021	K210134	Dentis s-Clean s-Line	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
March 18, 2021	K202773	s-Clean SQ-SL Implant System Mini	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
February 17, 2021	K210132	s-Clean SQ-SL Implant System Regular	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
April 13, 2020	K200099	s-Clean SQ-SL Implant System Mini	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
February 4, 2020	K192688	s-Clean SQ-SL Implant System Regular	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
December 7, 2018	K180657	Resin for Temporary Crown & Bridge	EBG	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
November 29, 2017	K171694	s-Clean TiN Coating Abutments	NHA	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
September 6, 2017	K171027	Dentis Dental Implant System	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
April 27, 2017	K170220	OneQ-SL s-Clean Implant System	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
December 7, 2016	K161244	s-Clean OneQ-SL Narrow Implant System	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
June 21, 2016	K160213	s-Clean Tapered II RBM Implant System	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
April 8, 2016	K153639	OneQ-SL s-Clean Implant System	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
December 10, 2015	K142313	OneQ-SL Implant System	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
July 24, 2015	K150344	Dentis Dental Implant System	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
February 1, 2012	K111364	HAPTITE COATING IMPLANT SYSTEM	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
June 19, 2009	K082843	MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
April 29, 2009	K083586	I-FIX SYSTEM	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov
April 1, 2009	K083569	SURGYBONE	DZI	Substantially Equivalent	Silfradent S.R.L.	accessdata.fda.gov
April 4, 2008	K073486	DENTIS DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Dentis Co., Ltd.	accessdata.fda.gov

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Updated March 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.