Home / 510(k) Clearances / K163251

510(k) K163251

Life Essence Universal Porcelain System by Blue Sky Bio — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2017
Date Received
November 18, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type

Other clearances by Blue Sky Bio

  • 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)
  • K153064 — Blue Sky Bio Zygomatic Implant System (April 29, 2016)
  • K112875 — BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS (January 27, 2012)

Other clearances for product code EIH

  • K253953 — IPS e.max Zirconia (March 10, 2026)
  • K254283 — BruxZir® Shaded 16 PLUS (January 30, 2026)
  • K253973 — Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series (January 9, 2026)
  • K252789 — Glass Ceramic (December 8, 2025)
  • K252446 — BruxZir® NOW (September 3, 2025)
  • K251593 — DenMat Multilayered Zirconia Disc (August 25, 2025)
  • K250063 — ARENA Star, Galaxy Star (July 10, 2025)
  • K250826 — Multi M Series (June 12, 2025)
  • K251084 — zirkon; structure; LFU shades, stains and glazes (June 5, 2025)
  • K250673 — CERABIEN MiLai (May 29, 2025)