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510(k) K080418

REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST by Regeneration Technologies, Inc. — Product Code NUN

K080418 is an FDA 510(k) premarket notification submitted by Regeneration Technologies, Inc. for the device "REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST". The FDA issued a decision of Substantially Equivalent on April 30, 2008. The device falls under product code NUN (Bone Grafting Material, Human Source), a Class II device regulated under 21 CFR 872.3930. Regeneration Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2008
Date Received
February 15, 2008
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 Regeneration Technologies, Inc.

  • K072238 — BIOSET XCH (January 25, 2008)
  • K072327 — CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON (October 24, 2007)
  • K063584 — STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID (May 9, 2007)
  • K060180 — BIOSET XC (September 6, 2006)
  • K060253 — STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST. (February 23, 2006)
  • K052405 — STERLING INTERFERENC SCREW HT (November 16, 2005)
  • K051615 — STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES (August 15, 2005)
  • K050767 — STERLING INTERFERENCE SCREW ST (June 9, 2005)
  • K043421 — OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC (February 16, 2005)
  • K043420 — OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE (February 10, 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)
  • K070147 — INTERGRO ORAL (May 14, 2007)
  • K060332 — ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY (March 29, 2006)
  • K060306 — ACCELL CONNEXUS DEMINERALIZED BONE MATRIX PUTTY (March 27, 2006)

FDA data resources