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510(k) K040501

DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX by Musculoskeletal Transplant Foundation — Product Code NUN

K040501 is an FDA 510(k) premarket notification submitted by Musculoskeletal Transplant Foundation for the device "DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX". The FDA issued a decision of Substantially Equivalent on April 29, 2005. The device falls under product code NUN (Bone Grafting Material, Human Source), a Class II device regulated under 21 CFR 872.3930. Musculoskeletal Transplant Foundation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2005
Date Received
February 26, 2004
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 Musculoskeletal Transplant Foundation

  • K181633 — MTF Pre-Sutured Tendon (March 15, 2019)
  • K121313 — MTF NEW BONE VOID FILLER (January 11, 2013)
  • K120479 — MTF FASCIA (November 8, 2012)
  • K113167 — MTF NEW BONE VOILD FILLER (January 24, 2012)
  • K110003 — MTF NEW BONE VOID FILLER (October 13, 2011)
  • K103795 — DBX DEMINERALIZED BONE MATRIX PUTTY (April 13, 2011)
  • K103784 — DBX DEMINERALIZED BONE MATRIX PUTTY (April 13, 2011)
  • K091217 — DBX DEMINERALIZED BONE MATRIX PUTTY (October 2, 2009)
  • K091218 — DBX DEMINERALIZED BONE MATRIX PUTTY (September 28, 2009)
  • K080399 — DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE (October 10, 2008)

Other clearances for product code NUN

  • K130235 — SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY (January 10, 2014)
  • 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)

FDA data resources