FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Absoanchor Microimplant
K Number: K181142
·
Decision Feb 5, 2019
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
50
Applicant Total
1
Review Days
280
Basic Information
- Device Name
- Absoanchor Microimplant
- K Number
- K181142
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dentos Inc
- Date Received
- May 1, 2018
- Decision Date
- February 5, 2019
- Product Code
- OAT
- 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 |
|---|---|---|---|
| OAT | Implant, Endosseous, Orthodontic | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OAT), ordered by most recent decision date.
Leone Orthodontic Implant TAD (Temporary Anchorage Device)
FDA 510(k)
FDA Class 2
·Dental
Mini Screws
FDA 510(k)
FDA Class 2
·Dental
T-FIT
FDA 510(k)
FDA Class 2
·Dental
ACR Screw System
FDA 510(k)
FDA Class 2
·Dental
Mico One Orthodontic Screw
FDA 510(k)
FDA Class 2
·Dental
Ortholock Anchorage Devices
FDA 510(k)
FDA Class 2
·Dental