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510(k) K110198

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

K110198 is an FDA 510(k) premarket notification submitted by Blue Sky Bio, LLC for the device "BLUE SKY BIO TCP". The FDA issued a decision of Substantially Equivalent on December 22, 2011. The device falls under product code LYC (Bone Grafting Material, Synthetic), a Class II device regulated under 21 CFR 872.3930. Blue Sky Bio, LLC has at least 10 other 510(k) clearances on record.

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.

Other clearances by Blue Sky Bio, LLC

  • K232653 — Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX (April 3, 2024)
  • K221845 — Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G (February 24, 2023)
  • K212785 — Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sk (June 30, 2022)
  • 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

  • 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