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510(k) K921468

PERMAMESH HYDROXYLAPATITE MATRIX by Ceramed Corp. — Product Code LYC

Clearance Details

Decision
SN ()
Decision Date
August 21, 1992
Date Received
March 27, 1992
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.

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  • 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)

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  • K201546 — OsOpia Synthetic Bone Void Filler (October 2, 2020)
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  • K192597 — Cytrans Granules (August 17, 2020)
  • K153676 — OSTEON III (September 14, 2016)