510(k) K051188

GRAFTON DBM by Osteotech, Inc. — Product Code NUN

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 3, 2006
Date Received: May 10, 2005
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 Osteotech, Inc.

K082615 — GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT (October 16, 2008)
K081227 — PLEXUR M (July 22, 2008)
K080511 — PLEXUR-P (April 21, 2008)
K073405 — PLEXUR M (March 3, 2008)
K061982 — PLEXUR P (February 7, 2007)
K051781 — GRAFTCAGE TLX (December 16, 2005)
K051195 — GRAFTON DBM (December 16, 2005)
K043209 — VIAGRAF DBM PASTE (December 5, 2005)
K053080 — GRAFTCAGE ACX (December 1, 2005)
K042707 — GRAFTON PLUS DBM PASTE (November 30, 2005)

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)