510(k) K090083

CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090 by Unicare Biomedical, Inc. — Product Code LYC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 23, 2009
Date Received: January 12, 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)
K092567 — MODIFICATION TO UNIGRAFT (November 25, 2009)
K090612 — BENACEL (July 24, 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

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)
K192597 — Cytrans Granules (August 17, 2020)
K153676 — OSTEON III (September 14, 2016)