Dental Collagen Wound Dressing (Nova Tape and NovaPlug)— 510(k) K142712
Substantially EquivalentNovabone Products, LLC
FDA 510(k) clearance K142712 for Dental Collagen Wound Dressing (Nova Tape and NovaPlug), Substantially Equivalent on 2015-01-08. Applicant: Novabone Products, LLC. Device class: Unclassified.
Clearance details
- Applicant
- Novabone Products, LLC
- Product code
- Code KGN
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alachua, FL, US
Recent devices under product code KGN
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view all- K242299 — NovaBone Putty - Synthetic Bioactive Bone Graft
- K240404 — NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)
- K220498 — NovoGen Wound Matrix
- K163310 — NovaBone IRM
- K152071 — NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)
Adverse events under product code KGN
product code KGN- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.