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510(k) K241186

Synthetic Bone Graft Particulate by Shenzhen Dazhou Medical Technology Co., Ltd. — Product Code LYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2025
Date Received
April 29, 2024
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 Shenzhen Dazhou Medical Technology Co., Ltd.

  • K241073 — DZ-Tabone Intervertebral Body Fusion Device (December 6, 2024)

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  • 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)
  • K153230 — ShefaBone SCPC Resorbable Bone Graft (July 14, 2016)