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510(k) K000149

NOVABONE-BIOGLASS BONE GRAFT PARTICULATE by Usbiomaterials Corp. — Product Code LYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2000
Date Received
January 19, 2000
Clearance Type
Special
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 Usbiomaterials Corp.

  • K024343 — BUTLER GUM PROPHY PASTE WITH NOVAMIN (July 11, 2003)
  • K992416 — PERIOGLAS- BIOGLASS BONE GRAFT PARTICULATE (October 15, 1999)
  • K962494 — PERIOGLAS - BIOGLASS BONE GRAFT PARTICULATE (September 20, 1996)
  • K930115 — PERIOGLASS (November 4, 1993)

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