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510(k) K902295

OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH by Ceramed Corp. — Product Code LYC

K902295 is an FDA 510(k) premarket notification submitted by Ceramed Corp. for the device "OSTEOGRAF/N NATURAL HYDROXYLAPATITE, 40-60 MESH". The FDA issued a decision of Substantially Equivalent on December 11, 1990. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Ceramed Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1990
Date Received
May 22, 1990
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)
  • K960368 — OSTEOGRAFT/N-700 HYDROXYLAPTITE (April 18, 1996)
  • K960353 — OSTEOGRAF/LD-300 HYDROXYLAPATITE (April 18, 1996)
  • K960361 — PERMAMESH-D HYDROXYLAPATITE MATRIX (April 15, 1996)
  • K960362 — PERMAMESH HYDROXYLAPATITE MATRIX (March 20, 1996)
  • K960354 — PERMAMESH-D 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

  • 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