Home / 510(k) Clearances / K092513

510(k) K092513

RAINBOW BLOCK by Genoss Co., Ltd. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2009
Date Received
August 17, 2009
Clearance Type
Abbreviated
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 Genoss Co., Ltd.

  • K242386 — Bluemoon (May 5, 2025)
  • K222688 — The Trust (August 9, 2024)
  • K233885 — rainbow Paste Stain SE (June 21, 2024)
  • K232174 — rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono (February 23, 2024)
  • K231480 — Bright MTA Sealer Plus (July 28, 2023)
  • K214086 — Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impres (December 15, 2022)
  • K200155 — Bright High Flow (November 30, 2020)
  • K200153 — Bright Bond Universal (October 28, 2020)
  • K200156 — Bright Low Flow (October 27, 2020)
  • K170596 — TN-Brush (September 11, 2017)

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)