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510(k) K093390

HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 by Depuy Spine, Inc. — Product Code LYC

K093390 is an FDA 510(k) premarket notification submitted by Depuy Spine, Inc. for the device "HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025". The FDA issued a decision of Substantially Equivalent on May 25, 2010. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Depuy Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2010
Date Received
October 29, 2009
Clearance Type
Special
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 Depuy Spine, Inc.

  • K222276 — CONDUIT Cages; FIBERGRAFT BG Putty (October 15, 2022)
  • K201831 — CONFIDENCE Spinal Cement System (August 31, 2020)
  • K142185 — EXPEDIUM VERSE SPINE SYSTEM (November 19, 2014)
  • K111136 — EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM (June 14, 2012)
  • K121020 — VIPER SYSTEM (May 3, 2012)
  • K110353 — MOUNTAINEER OCT SPINAL SYSTEM (April 7, 2011)
  • K110216 — EXPEDIUM SYSTEM, VIPER SYSTEM (April 1, 2011)
  • K103133 — VEPER SYSTEM, EXPEDIUM SYSTEM (January 18, 2011)
  • K101993 — VIPER SYSTEM, EXPEDIUM SYSTEM (December 7, 2010)
  • K101923 — CONCORDE CURVE SYSTEM (December 1, 2010)

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