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510(k) K092567

MODIFICATION TO UNIGRAFT by Unicare Biomedical, Inc. — Product Code LYC

K092567 is an FDA 510(k) premarket notification submitted by Unicare Biomedical, Inc. for the device "MODIFICATION TO UNIGRAFT". The FDA issued a decision of Substantially Equivalent on November 25, 2009. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Unicare Biomedical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2009
Date Received
August 20, 2009
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 Unicare Biomedical, Inc.

  • K151344 — Cytoflex Tefguard Ti-Enforced Membrane (November 19, 2015)
  • K090612 — BENACEL (July 24, 2009)
  • K090083 — CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 (March 23, 2009)
  • K080532 — BENACEL, MODELS C-001, C-002 AND C-005 (November 12, 2008)
  • K021511 — CYTOFLEX MESH (August 6, 2002)
  • K020720 — OSSIFORM (May 7, 2002)
  • K012144 — CYTOFLEX (October 1, 2001)
  • K003457 — UNIGRAFT (January 9, 2001)
  • K993784 — UNIGRAFT (January 27, 2000)
  • K982699 — UNIGRAFE (October 20, 1998)

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