FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
J2A SLA Dental Implant System
K Number: K161923
·
Decision Nov 9, 2017
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
12
Review Days
484
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- J2A SLA Dental Implant System
- K Number
- K161923
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kj Meditech Co., Ltd.
- Date Received
- July 13, 2016
- Decision Date
- November 9, 2017
- Product Code
- DZE
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZE), ordered by most recent decision date.
MegaGen Zygoma Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
INOSS System
FDA 510(k)
FDA Class 2
·Dental
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
FDA 510(k)
FDA Class 2
·Dental
Adin Long Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
ZENEX Implant System_Short (R-System)
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Kj Meditech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K202046 | LOTA SLA Dental Implant System and LOTA HA Dental Implant System | Mar 1, 2022 | Substantially Equivalent |
| K173116 | KJ ZIRCONIA Implant System | Jun 28, 2018 | Substantially Equivalent |
| K151970 | KJ Mini Implant System | Oct 21, 2016 | Substantially Equivalent |
| K150060 | J2A Dental Implant System, J2C Dental Implant System | Apr 2, 2015 | Substantially Equivalent |
| K140051 | KJ EXTERNAL IMPLANT SYSTEM | Oct 30, 2014 | Substantially Equivalent |
| K140052 | J2I IMPLANT SYSTEM | Oct 30, 2014 | Substantially Equivalent |
| K121098 | HERO I DENTAL IMPLANT SYSTEM | Jan 17, 2013 | Substantially Equivalent |
| K121047 | HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM | Oct 4, 2012 | Substantially Equivalent |
| K112787 | KERATOR | Aug 8, 2012 | Substantially Equivalent |
| K103810 | KJ SUBMERGED SYSTEM | Sep 14, 2011 | Substantially Equivalent |