510(k) K861041

ENHANCE by Packaging Technologies, Inc. — Product Code LYC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 30, 1986
Date Received: March 18, 1986
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 Packaging Technologies, Inc.

K881756 — STERILE SURGEONS GLOVES (June 1, 1988)
K863326 — BONE MARROW TRAY (September 16, 1986)
K850544 — SHAVE PREP TRAY (March 12, 1985)
K850438 — RENAL BIOPSY TRAY (February 26, 1985)
K844613 — GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR (January 10, 1985)
K844614 — IV START KIT (December 19, 1984)
K844611 — SINGLE BASIN SET (December 19, 1984)
K844612 — ACUTE HEMODIALYSIS TRAYS (December 17, 1984)
K834074 — PERCUTANEOUS SHEATH INTRODUCER TRAY (March 19, 1984)
K834073 — CENTRAL VEIN CATHERIZATION TRAY CC-20 (February 28, 1984)

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)