Dentis s-Clean SQ-SL Narrow Implant System

FDA 510(k) K230246 · Dentis Co., Ltd.

Substantially Equivalent

510(k) numberK230246

Submission

Device name
Dentis s-Clean SQ-SL Narrow Implant System
Applicant
Dentis Co., Ltd.
Daegu, KR
Received
January 30, 2023
Decision date
May 25, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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More from Hiossen, Inc.

510(k)DeviceDecision
K253493Dentis SQ-SL AXEL FixtureDZE · Traditional 03/04/2026SE
K241065ChecQ (AC100)EKX · Traditional 03/21/2025SE
K233921Luvis Chair (LC700C)KLC · Traditional 09/06/2024SE
K241063s-Clean ScanHealing AbutmentNHA · Traditional 07/25/2024SE
K240511Dentis s-Clean SQ-SL FixtureDZE · Traditional 05/20/2024SE
K233544MesheetNXC · Traditional 02/22/2024SE
K230126Dentis s-Clean Regular AbutmentNHA · Traditional 08/04/2023SE
K230307Dentis i-Clean SystemNHA · Traditional 07/11/2023SE
K230523s-Clean Link Abutment NarrowNHA · Traditional 05/24/2023SE
K230203Dentis I-FIX AbutmentNHA · Traditional 05/03/2023SE

Questions and answers

When was Dentis s-Clean SQ-SL Narrow Implant System cleared by the FDA?

Dentis s-Clean SQ-SL Narrow Implant System (K230246) received a 510(k) decision of Substantially Equivalent on May 25, 2023, 115 days after the submission was received.

What is the product code of K230246?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.