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510(k) K072058

MODIFICATION TO: OSTEOGRAF/N-700 by Dentsply Interntional — Product Code LYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2007
Date Received
July 26, 2007
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.

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Other clearances for product code LYC

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  • K213260 — CMFlexTM (December 30, 2022)
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  • 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)