510(k) K110198

BLUE SKY BIO TCP by Blue Sky Bio, LLC — Product Code LYC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 22, 2011
Date Received: January 24, 2011
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.

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K202026 — Blue Sky Bio CAD-CAM Abutments (December 18, 2020)
K201919 — Blue Sky Bio TAD (December 17, 2020)
K190491 — Blue Sky Bio Zygomatic Implant System (August 12, 2019)
K182338 — Blue Sky Bio Computerized Orthodontic Bracket System (November 9, 2018)
K180107 — Blue Sky Bio Aligner (February 9, 2018)
K163251 — Life Essence Universal Porcelain System (August 4, 2017)
K153064 — Blue Sky Bio Zygomatic Implant System (April 29, 2016)

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)