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510(k) K160474

DSM Biomedical Porcine Pericardium Dental Membrane by Kensey Nash Corporation Dba Dsm Biomedical — Product Code NPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2016
Date Received
February 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Barrier, Animal Source, Intraoral
Device Class
Class II
Regulation Number
872.3930
Review Panel
DE
Submission Type

An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.

Other clearances by Kensey Nash Corporation Dba Dsm Biomedical

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  • K173362 — DSM Biomedical Calcium Phosphate Cement (April 3, 2018)
  • K170245 — DSM Biomedical Dental Bone Graft (May 16, 2017)
  • K141738 — MEDEOR MATRIX WOUND DRESSING (February 17, 2015)
  • K133169 — MESO TENDON MATRIX (December 20, 2013)
  • K132025 — MESO BILAYER SURGICAL MESH (October 30, 2013)

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