FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SWISSPLANT DENTAL IMPLANT SYSTEM
K Number: K081396
·
Decision Jan 14, 2009
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
10
Review Days
240
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
- SWISSPLANT DENTAL IMPLANT SYSTEM
- K Number
- K081396
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implant Direct, LLC
- Date Received
- May 19, 2008
- Decision Date
- January 14, 2009
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NHA), ordered by most recent decision date.
Neodent Scannable Healing Abutment
FDA 510(k)
FDA Class 2
·Dental
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)
FDA 510(k)
FDA Class 2
·Dental
DESS Dental Smart Solutions
FDA 510(k)
FDA Class 2
·Dental
SIC Abutments including CAD/CAM Solutions
FDA 510(k)
FDA Class 2
·Dental
Elos Accurate® Denture Fixation System
FDA 510(k)
FDA Class 2
·Dental
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Implant Direct, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K090234 | SPECTRA SYSTEM DENTAL IMPLANTS 2008 | May 15, 2009 | Substantially Equivalent |
| K081101 | SPECTRA-SYSTEM ABUTMENTS 2008 | Jan 14, 2009 | Substantially Equivalent |
| K080633 | SCREWINDIRECT DENTAL IMPLANTS | Jul 15, 2008 | Substantially Equivalent |
| K080713 | REACTIVE DENTAL IMPLANT SYSTEM | May 16, 2008 | Substantially Equivalent |
| K073161 | REPLUS DENTAL IMPLANTS (HA) | Mar 7, 2008 | Substantially Equivalent |
| K073049 | SCREWPLUS DENTAL IMPLANTS (HA) | Dec 13, 2007 | Substantially Equivalent |
| K073033 | LEGACY DENTAL IMPLANTS | Dec 10, 2007 | Substantially Equivalent |
| K061319 | SPECTRA SYSTEM | Sep 29, 2006 | Substantially Equivalent |
| K060063 | LEGACY ABUTMENT SYSTEM | May 19, 2006 | Substantially Equivalent |