FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
IS-III active System_S-narrow Type
K Number: K190849
·
Decision Aug 14, 2019
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
17
Review Days
135
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
- IS-III active System_S-narrow Type
- K Number
- K190849
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neobiotech Co., Ltd.
- Date Received
- April 1, 2019
- Decision Date
- August 14, 2019
- 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 Neobiotech Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K232528 | Protective Cap | Apr 30, 2024 | Substantially Equivalent |
| K232049 | IS-III active Short Implant | Mar 28, 2024 | Substantially Equivalent |
| K210903 | IS Multi Unit Abutment System | Jul 23, 2021 | Substantially Equivalent |
| K181137 | IT-III active System | Nov 16, 2018 | Substantially Equivalent |
| K181138 | IS-III active System | Oct 3, 2018 | Substantially Equivalent |
| K181178 | S-mini active Fixture | Jul 24, 2018 | Substantially Equivalent |
| K173938 | IS-III HActive Fixture | May 24, 2018 | Substantially Equivalent |
| K160991 | Neo GBR System | Jan 10, 2017 | Substantially Equivalent |
| K120503 | CMI IMPLANT IS II ACTIVE | Jun 18, 2012 | Substantially Equivalent |
| K113554 | CMI IMPLANT IS SYSTEM | Apr 5, 2012 | Substantially Equivalent |