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510(k) K130235

SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY by Hans Biomed Corp. — Product Code NUN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2014
Date Received
January 30, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Grafting Material, Human Source
Device Class
Class II
Regulation Number
872.3930
Review Panel
DE
Submission Type

INTENDED TO BE PACKED INTO BONY VOIDS OR GAPS TO FILL AND/OR AUGMENT DENTAL INTRAOSSEOUS, ORAL AND CRANIO-/MAXILLOFACIAL DEFECTS. THESE DEFECTS MAY BE SURGICALLY CREATD OSSEOUS DEFECTS OR OSSEOUS DEFECTS CREATED FROM TRAUMATIC INJRY TO THE BONE, INLCUDING PERIODENTA/INFRABONY DEFECTS; ALVEOLAR RIDGE AUGMENTATION (SINUSOTOMY, OSTEOTOMY, CYSTECTOMY); DENTAL EXTRACTION SITES (RIDGE MAINTENANCE, IMPLANT PREPARATION/PLACEMENT); SINUS LIFTS; CYSTIC DEFECTS; CRANIOFACIAL AUGMENTATION.

Other clearances by Hans Biomed Corp.

  • K152077 — MaxiGen (April 21, 2016)
  • K151271 — BellaFuse (March 11, 2016)
  • K113728 — SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY (November 15, 2012)

Other clearances for product code NUN

  • K113645 — REGENEROSS ALLOGRAFT PLUS MINERLIZED (January 20, 2012)
  • K103699 — EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC (August 12, 2011)
  • K091217 — DBX DEMINERALIZED BONE MATRIX PUTTY (October 2, 2009)
  • K082463 — PROGENIX (November 10, 2008)
  • K081950 — PROGENIX PLUS (July 18, 2008)
  • K080462 — PROGENIX DBM PUTTY (May 13, 2008)
  • K080418 — REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIP (April 30, 2008)
  • K070147 — INTERGRO ORAL (May 14, 2007)
  • K060332 — ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY (March 29, 2006)
  • K060306 — ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY (March 27, 2006)