MU System
FDA 510(k) K222976 · Dentis Co., Ltd.
510(k) numberK222976
Submission
- Device name
- MU System
- Applicant
- Dentis Co., Ltd.
Daegu, KR - Received
- September 28, 2022
- Decision date
- January 12, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NHA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…NHA · Traditional | Nobel Biocare AB | 08/06/2026SE |
| K261147 | Neodent Implant System - NeoConvert FitNHA · Traditional | JJGC Indústria e Comércio de Materiais Dentários… | 07/01/2026SE |
| K261122 | Mist IcNHA · Traditional | Imagine Milling Technologies, LLC | 06/27/2026SE |
| K260061 | BioHorizons CEREC Compatible Ti-BasesNHA · Traditional | BioHorizons Implant Systems, Inc. | 06/26/2026SE |
| K253922 | Neodent Scannable Healing AbutmentNHA · Traditional | JJGC Indústria e Comércio de Materiais Dentários… | 06/15/2026SE |
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)NHA · Abbreviated | Smart Denture Conversions, LLC | 06/11/2026SE |
| K260564 | DESS Dental Smart SolutionsNHA · Traditional | Terrats Medical SL | 06/09/2026SE |
| K252904 | SIC Abutments including CAD/CAM SolutionsNHA · Traditional | Sic Invent AG | 06/03/2026SE |
| K253774 | Elos Accurate® Denture Fixation SystemNHA · Traditional | Elos Medtech Pinol A/S | 05/20/2026SE |
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsNHA · Traditional | Hiossen, Inc. | 05/14/2026SE |
More from Hiossen, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253493 | Dentis SQ-SL AXEL FixtureDZE · Traditional | 03/04/2026SE |
| K241065 | ChecQ (AC100)EKX · Traditional | 03/21/2025SE |
| K233921 | Luvis Chair (LC700C)KLC · Traditional | 09/06/2024SE |
| K241063 | s-Clean ScanHealing AbutmentNHA · Traditional | 07/25/2024SE |
| K240511 | Dentis s-Clean SQ-SL FixtureDZE · Traditional | 05/20/2024SE |
| K233544 | MesheetNXC · Traditional | 02/22/2024SE |
| K230126 | Dentis s-Clean Regular AbutmentNHA · Traditional | 08/04/2023SE |
| K230307 | Dentis i-Clean SystemNHA · Traditional | 07/11/2023SE |
| K230246 | Dentis s-Clean SQ-SL Narrow Implant SystemNHA · Traditional | 05/25/2023SE |
| K230523 | s-Clean Link Abutment NarrowNHA · Traditional | 05/24/2023SE |
Questions and answers
When was MU System cleared by the FDA?
MU System (K222976) received a 510(k) decision of Substantially Equivalent on January 12, 2023, 106 days after the submission was received.
What is the product code of K222976?
The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.