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510(k) K240882

BruxZir® Esthetic by Prismatik Dentalcraft, Inc. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2024
Date Received
April 1, 2024
Clearance Type
Special
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

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  • K250302 — Flexible Partial Resin (June 25, 2025)
  • K242564 — Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ (March 21, 2025)
  • K250223 — BruxZir® Esthetic NOW (February 25, 2025)
  • K241493 — Glidewell™ 3DP Denture Base Resin (September 12, 2024)
  • K240240 — Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Ne (July 12, 2024)
  • K231940 — BruxZir® NOW SRC (May 15, 2024)
  • K240574 — BruxZir® Radiant (March 20, 2024)

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)