Home / 510(k) Clearances / K221242

510(k) K221242

Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank by Hunan Vsmile Biotechnology Co., Ltd. — Product Code EIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2022
Date Received
May 2, 2022
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 Hunan Vsmile Biotechnology Co., Ltd.

  • K242407 — Dental Glass Ceramics Blocks (HT, LT, MT) (November 13, 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)