FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Dental Collagen Wound Dressing (Nova Tape and NovaPlug)
K Number: K142712
·
Decision Jan 8, 2015
Classifications
1
FEI Numbers
134
Registration Numbers
134
Same Product Code
187
Applicant Total
30
Review Days
108
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Basic Information
- Device Name
- Dental Collagen Wound Dressing (Nova Tape and NovaPlug)
- K Number
- K142712
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Novabone Products, LLC
- Date Received
- September 22, 2014
- Decision Date
- January 8, 2015
- Product Code
- KGN
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | FDA unclassified | Unknown |
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| K112773 | NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT | Oct 14, 2011 | Substantially Equivalent |
| K110925 | NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT | Jul 5, 2011 | Substantially Equivalent |