FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REACTIVE DENTAL IMPLANT SYSTEM
K Number: K080713
·
Decision May 16, 2008
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
10
Review Days
64
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Basic Information
- Device Name
- REACTIVE DENTAL IMPLANT SYSTEM
- K Number
- K080713
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Implant Direct, LLC
- Date Received
- March 13, 2008
- Decision Date
- May 16, 2008
- 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 |
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Other Clearances by Implant Direct, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K090234 | SPECTRA SYSTEM DENTAL IMPLANTS 2008 | May 15, 2009 | Substantially Equivalent |
| K081396 | SWISSPLANT DENTAL IMPLANT SYSTEM | Jan 14, 2009 | Substantially Equivalent |
| K081101 | SPECTRA-SYSTEM ABUTMENTS 2008 | Jan 14, 2009 | Substantially Equivalent |
| K080633 | SCREWINDIRECT DENTAL IMPLANTS | Jul 15, 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 |