FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
UNO NARROW IMPLANT
K Number: K092555
·
Decision Jan 5, 2010
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
13
Review Days
138
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
- UNO NARROW IMPLANT
- K Number
- K092555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mis Implants Technologies , Ltd.
- Date Received
- August 20, 2009
- Decision Date
- January 5, 2010
- 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 Mis Implants Technologies , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K182228 | MIS LOCKiT Abutments System, OT-Equators and Ball Attachments | Jan 28, 2019 | Substantially Equivalent |
| K180282 | MIS Internal Hex Dental Implant System | Jun 22, 2018 | Substantially Equivalent |
| K173326 | MIS CONNECT Conical Connection Abutment | Mar 16, 2018 | Substantially Equivalent |
| K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments | Dec 28, 2017 | Substantially Equivalent |
| K163349 | MIS V3 Conical Connection Dental Implant System | May 26, 2017 | Substantially Equivalent |
| K112162 | CONICAL CONNECTION IMPLANTS | Aug 8, 2012 | Substantially Equivalent |
| K110750 | PERIOPATCH | Apr 28, 2011 | Substantially Equivalent |
| K101014 | BOND BONE | Oct 21, 2010 | Substantially Equivalent |
| K080162 | UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT | Apr 22, 2008 | Substantially Equivalent |
| K073461 | ORTHO ANCHOR SCREWS | Jan 25, 2008 | Substantially Equivalent |