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510(k) K092788

PERIOPHIL BIPHASIC by Cytophil, Inc. — Product Code LYC

K092788 is an FDA 510(k) premarket notification submitted by Cytophil, Inc. for the device "PERIOPHIL BIPHASIC". The FDA issued a decision of Substantially Equivalent on December 18, 2009. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Cytophil, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2009
Date Received
September 10, 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 Cytophil, Inc.

  • K150400 — Renu Gel (April 6, 2015)
  • K121795 — CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT (February 22, 2013)
  • K102937 — OSTEOPHIL BETA-TCP (December 27, 2010)
  • K093871 — PERIOPHIL B-TCP (April 22, 2010)
  • K081816 — VOCALIS AND VOCALIS SM (January 5, 2009)
  • K081815 — VOCALIS GEL (January 5, 2009)
  • K072219 — CYTOPHIL TISSUE MARKER (January 18, 2008)

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