Home / 510(k) Clearances / K170885

510(k) K170885

DD cubeX2 HS by Dental Direkt GmbH — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2017
Date Received
March 27, 2017
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 Dental Direkt GmbH

  • K241579 — DD Hybridlayer (multicolored zirconia) (September 6, 2024)
  • K230410 — DD medical polymers (PMMA) (June 23, 2023)
  • K230218 — DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) (April 25, 2023)
  • K191111 — DD Solid Connect® CAD/CAM Abutments (January 11, 2023)
  • K193588 — DD Contrast (April 16, 2020)
  • K183569 — DD cube ONE ML (February 14, 2019)
  • K153490 — DD medical polymers (May 13, 2016)
  • K150196 — DD cubeX2 (March 26, 2015)

Other clearances for product code EIH

  • K260067 — Eternal Art Porcelain Powders (April 9, 2026)
  • K260370 — Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (March 30, 2026)
  • 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)