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510(k) K261404

UltraEZ by Ultradent Products, Inc. — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2026
Date Received
April 29, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type

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Other clearances for product code LBH

  • K252073 — VOCO Profluorid Varnish + BioMin (May 1, 2026)
  • K260830 — APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) (March 18, 2026)
  • K250714 — FluoroDose Varnish (November 21, 2025)
  • K243777 — Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Var (May 27, 2025)
  • K241489 — ReminGel (January 8, 2025)
  • K241568 — CrystLCare™ PRO Biorestorative, Fluoride-Plus (January 2, 2025)
  • K242913 — Jasmate® Toothpaste (November 22, 2024)
  • K233768 — Papacarie Duo (July 18, 2024)
  • K231060 — ProMin Dental Desensitizing Gel (June 13, 2024)
  • K230333 — Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal (July 24, 2023)