510(k) K091729

ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE by Etex Corp. — Product Code LYC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 23, 2009
Date Received: June 11, 2009
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 Etex Corp.

K100883 — CARRIGEN (December 21, 2010)
K101557 — GAMMA-BSM, BETA-BSM, EQUIVABONE, CARIGEN (July 1, 2010)
K093447 — CARRIGEN (February 18, 2010)
K091607 — ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE (November 2, 2009)
K090855 — EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE (September 18, 2009)
K090310 — EQUIVABONE (March 24, 2009)
K090242 — GAMMA-BSM, BETA-BSM (February 20, 2009)
K080329 — CAP PLUS, EQUIVABONE, CAP/DBM (April 28, 2008)
K063050 — CAP PLUS (November 19, 2007)
K072636 — A-BSM BONE SUBSTITUTE MATERIAL (October 23, 2007)

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)