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510(k) K202952

Amber Mill Q Series & Amber Mill Direct Series by Hass Corp. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2021
Date Received
September 30, 2020
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 Hass Corp.

  • K260859 — Rosetta SM, Rosetta SP (June 11, 2026)
  • K160102 — Amber Mill Series and Amber Press Series (July 14, 2016)
  • K111573 — MONOBLOC BM SERIES (August 26, 2011)
  • K102305 — HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P (December 3, 2010)

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)