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510(k) K070055

BONALIVE GRANULES AND BONALIVE PLATES by Vivoxid , Ltd. — Product Code LYC

K070055 is an FDA 510(k) premarket notification submitted by Vivoxid , Ltd. for the device "BONALIVE GRANULES AND BONALIVE PLATES". The FDA issued a decision of Substantially Equivalent on June 25, 2007. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Vivoxid , Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2007
Date Received
January 4, 2007
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 Vivoxid , Ltd.

  • K071199 — BONALIVE GRANULES (February 1, 2008)
  • K071937 — BONALIVE GRANULES AND BONALIVE PLATES (October 19, 2007)

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