510(k) K041324

CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER by Lifecore Biomedical, Inc. — Product Code LYC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 19, 2004
Date Received: May 18, 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 Lifecore Biomedical, Inc.

K073032 — PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS (November 16, 2007)
K072241 — PRIMACONNEX CAD/CAM ABUTMENT SYSTEM (November 9, 2007)
K072768 — RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS (October 23, 2007)
K072572 — PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS (October 5, 2007)
K062876 — PRIMACONNEX CERAMIC ABUTMENTS (November 1, 2006)
K060530 — SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING F (May 22, 2006)
K053643 — STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 (January 23, 2006)
K051614 — PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION (September 9, 2005)
K050506 — PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS (April 15, 2005)
K032774 — RENOVA INTERNAL HEX IMPLANT SYSTEM (November 26, 2003)

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)