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510(k) K060332

ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY by Isotis NV — Product Code NUN

K060332 is an FDA 510(k) premarket notification submitted by Isotis NV for the device "ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY". The FDA issued a decision of Substantially Equivalent on March 29, 2006. The device falls under product code NUN (Bone Grafting Material, Human Source), a Class II device regulated under 21 CFR 872.3930. Isotis NV has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2006
Date Received
February 9, 2006
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 Isotis NV

  • K061880 — ACCELI DBM FAMILY PRODUCTS, 0.5CC, 1CC, 2.5CC, 5CC, 10CC, 15CC, 30CC (August 15, 2007)
  • K060306 — ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY (March 27, 2006)
  • K031813 — OSSATURA DENTAL (August 20, 2004)
  • K041344 — OPEN BORE SYRINGE (July 16, 2004)
  • K030131 — OSSATURA BCP BONE VOID FILLER (May 20, 2003)
  • K010840 — SYNPLUG (April 20, 2001)
  • K000587 — SHUTTLE STOP (May 4, 2000)

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)
  • K060306 — ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY (March 27, 2006)

FDA data resources