510(k) K060332

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

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

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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)

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K103699 — EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC (August 12, 2011)
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K082463 — PROGENIX (November 10, 2008)
K081950 — PROGENIX PLUS (July 18, 2008)
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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)