510(k) K942946

OSTEOGRAF/D-100 HYDROXYLAPATITE by Ceramed Corp. — Product Code LYC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 5, 1994
Date Received: June 23, 1994
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 Ceramed Corp.

K962838 — PERMARIDGE SYRINGE (August 20, 1996)
K962786 — OSTEOGRAF STAINLESS STEEL SYRING (August 1, 1996)
K960348 — OSTEOGRAF/N-300 HYDROXYLAPATITE (April 22, 1996)
K960353 — OSTEOGRAF/LD-300 HYDROXYLAPATITE (April 18, 1996)
K960368 — OSTEOGRAFT/N-700 HYDROXYLAPTITE (April 18, 1996)
K960361 — PERMAMESH-D HYDROXYLAPATITE MATRIX (April 15, 1996)
K960354 — PERMAMESH-D HYDROXYLAPATITE MATRIX (March 20, 1996)
K960362 — PERMAMESH HYDROXYLAPATITE MATRIX (March 20, 1996)
K960349 — PERMARIDGE HYDROXYLAPATITE MATRIX (March 13, 1996)
K954631 — OSTEOGRAF/N-BLOCCK HYDROXYLAPATITE (January 2, 1996)

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)