MIS Internal Hex Dental Implant System
FDA 510(k) K180282 · Mis Implants Technologies , Ltd.
510(k) numberK180282
Submission
- Device name
- MIS Internal Hex Dental Implant System
- Applicant
- Mis Implants Technologies , Ltd.
Bar Lev Industrial Park, IL - Received
- January 31, 2018
- Decision date
- June 22, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K251232 | MegaGen Zygoma Dental Implant SystemDZE · Traditional | Megagen Implant Co., Ltd. | 06/18/2026SE |
| K250806 | Dental Implant SystemDZE · Traditional | A.B. Dental Devices , Ltd. | 06/18/2026SE |
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| K252031 | Adin Long Dental Implant SystemDZE · Traditional | Adin Dental Implant Systems , Ltd. | 03/23/2026SE |
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| K252168 | Straumann® BLC Implants - Indication WideningDZE · Traditional | Institut Straumann AG | 03/10/2026SE |
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More from Dentis Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K182228 | MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsNHA · Traditional | 01/28/2019SE |
| K173326 | MIS CONNECT Conical Connection AbutmentNHA · Traditional | 03/16/2018SE |
| K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…DZE · Traditional | 12/28/2017SE |
| K163349 | MIS V3 Conical Connection Dental Implant SystemDZE · Traditional | 05/26/2017SE |
| K112162 | Conical Connection ImplantsDZE · Traditional | 08/08/2012SE |
| K110750 | PeriopatchOLR · Traditional | 04/28/2011SE |
| K101014 | Bond BoneLYC · Traditional | 10/21/2010SE |
| K092555 | Uno Narrow ImplantDZE · Traditional | 01/05/2010SE |
| K080162 | Uno - One Piece Screw-Type Dental ImplantDZE · Traditional | 04/22/2008SE |
| K073461 | Ortho Anchor ScrewsOAT · Traditional | 01/25/2008SE |
Questions and answers
When was MIS Internal Hex Dental Implant System cleared by the FDA?
MIS Internal Hex Dental Implant System (K180282) received a 510(k) decision of Substantially Equivalent on June 22, 2018, 142 days after the submission was received.
What is the product code of K180282?
The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.