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510(k) K950165

INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS by Interpore Intl. — Product Code LYC

K950165 is an FDA 510(k) premarket notification submitted by Interpore Intl. for the device "INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS". The FDA issued a decision of Substantially Equivalent on March 28, 1995. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Interpore Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1995
Date Received
January 17, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Grafting Material, Synthetic
Device Class
Class II
Regulation Number
872.3930
Review Panel
DE
Submission Type

A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.

Other clearances by Interpore Intl.

  • K981253 — ULTRACON ULTRAFILTRATOR (December 11, 1998)
  • K980817 — PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5R (September 25, 1998)
  • K972842 — INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE (October 30, 1997)
  • K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (June 3, 1997)
  • K960945 — IMZ MEMBRANE TACK SYSTEM (May 24, 1996)
  • K960371 — INTERPORE THREADED IMPLANT (March 8, 1996)
  • K955492 — INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT (January 30, 1996)
  • K952167 — IMZ BONE TACK SYSTEM (November 21, 1995)
  • K922872 — INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM. (July 25, 1994)
  • K922732 — INTERPORE CYLINDRICAL HEX IMPLANT, 3.3 MM DIAMETER (February 10, 1994)

Other clearances for product code LYC

  • K253317 — Cytrans™ Elashield (July 6, 2026)
  • K253883 — Bonalive Maxillofacial (May 14, 2026)
  • K251818 — BONTREE PLUS (March 6, 2026)
  • K244006 — FG Bone Graft M (September 17, 2025)
  • K243745 — FG Bone Graft B (August 29, 2025)
  • K241186 — Synthetic Bone Graft Particulate (February 21, 2025)
  • K213260 — CMFlexTM (December 30, 2022)
  • K202675 — InRoad® Dental Synthetic Bone Graft (March 4, 2022)
  • K201546 — OsOpia Synthetic Bone Void Filler (October 2, 2020)
  • K201051 — Straumann BoneCeramic (September 24, 2020)

FDA data resources