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510(k) K233161

BeautiLink SA by Shofu Dental Corporation — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2023
Date Received
September 27, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

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Other clearances for product code EMA

  • K254063 — iCEM Universal Plus (December 19, 2025)
  • K252785 — TopCEM Vigor SA Self-Adhesive Resin Cement (December 12, 2025)
  • K252808 — GlasIonomer FX-LC (December 9, 2025)
  • K252165 — ZIRCONOMER P (October 28, 2025)
  • K250953 — EQUIA LC ONE (September 19, 2025)
  • K251775 — RODIN Cement (September 2, 2025)
  • K250156 — Choice 2 DC (July 11, 2025)
  • K251470 — ResiCem EX (July 11, 2025)
  • K250566 — EsCem RMGI (June 20, 2025)
  • K242366 — OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abut (January 10, 2025)