510(k) K042706

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

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

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)
K192597 — Cytrans Granules (August 17, 2020)
K153676 — OSTEON III (September 14, 2016)