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510(k) K142712

Dental Collagen Wound Dressing (Nova Tape and NovaPlug) by Novabone Products, LLC — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2015
Date Received
September 22, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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  • K152071 — NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (August 26, 2015)
  • K141207 — NOVABONE BIOACTIVE STRIP (October 31, 2014)
  • K140946 — NOVABONE MACROFORM BIOACTIVE PACKABLE, NOVABONE MACROFORM BIOACTIVE COMPOSITE (August 22, 2014)
  • K112428 — NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT (December 16, 2011)
  • K112773 — NOVABNE PUTTY BIOACTIVE SYNTHETIC BONE GRAFT (October 14, 2011)
  • K110925 — NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT (July 5, 2011)

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