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510(k) K241579

DD Hybridlayer (multicolored zirconia) by Dental Direkt GmbH — Product Code EIH

K241579 is an FDA 510(k) premarket notification submitted by Dental Direkt GmbH for the device "DD Hybridlayer (multicolored zirconia)". The FDA issued a decision of Substantially Equivalent on September 6, 2024. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660. Dental Direkt GmbH has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2024
Date Received
June 3, 2024
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

  • 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)
  • K170885 — DD cubeX2 HS (August 1, 2017)
  • K153490 — DD medical polymers (May 13, 2016)
  • K150196 — DD cubeX2 (March 26, 2015)

Other clearances for product code EIH

  • K260859 — Rosetta SM, Rosetta SP (June 11, 2026)
  • K253191 — DCMhotbond zircon (May 21, 2026)
  • 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)

FDA data resources