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510(k) K042706

OSSATURA DENTAL by Isotis Orthobiologics, Inc. — Product Code LYC

K042706 is an FDA 510(k) premarket notification submitted by Isotis Orthobiologics, Inc. for the device "OSSATURA DENTAL". The FDA issued a decision of Substantially Equivalent on October 20, 2004. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Isotis Orthobiologics, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2004
Date Received
September 30, 2004
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 Isotis Orthobiologics, Inc.

  • K091193 — ACCELL EVO3C (August 10, 2009)
  • K081817 — ACCELL TBM-R (September 24, 2008)
  • K070751 — ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY (October 15, 2007)
  • K050642 — ORTHOBLAST II PUTTY AND PASTE (December 5, 2005)
  • K052098 — CONNEXUS, .5CC, MODEL 023000-005 (September 7, 2005)
  • K043573 — DYNAGRAFT II DENTAL (July 29, 2005)
  • K050690 — CONNEXUS (July 7, 2005)
  • K040419 — DYNAGRAFT II (March 25, 2005)
  • K041991 — ASPIREX - BONE MARROW ASPIRATE KIT (September 16, 2004)

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