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510(k) K043573

DYNAGRAFT II DENTAL by Isotis Orthobiologics, Inc. — Product Code NUN

K043573 is an FDA 510(k) premarket notification submitted by Isotis Orthobiologics, Inc. for the device "DYNAGRAFT II DENTAL". The FDA issued a decision of Substantially Equivalent on July 29, 2005. The device falls under product code NUN (Bone Grafting Material, Human Source), a Class II device regulated under 21 CFR 872.3930. Isotis Orthobiologics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2005
Date Received
December 27, 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 Isotis Orthobiologics, Inc.

  • K091193 — ACCELL EVO3C (August 10, 2009)
  • K081817 — ACCELL TBM-R (September 24, 2008)
  • K070751 — ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY (October 15, 2007)
  • K050642 — ORTHOBLAST II PUTTY AND PASTE (December 5, 2005)
  • K052098 — CONNEXUS, .5CC, MODEL 023000-005 (September 7, 2005)
  • K050690 — CONNEXUS (July 7, 2005)
  • K040419 — DYNAGRAFT II (March 25, 2005)
  • K042706 — OSSATURA DENTAL (October 20, 2004)
  • K041991 — ASPIREX - BONE MARROW ASPIRATE KIT (September 16, 2004)

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