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510(k) K232498

UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio by Ultradent Product, Inc. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2023
Date Received
August 17, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Sealant, Pit And Fissure, And Conditioner
Device Class
Class II
Regulation Number
872.3765
Review Panel
DE
Submission Type

Other clearances by Ultradent Product, Inc.

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  • K190339 — Helioseal F Plus (July 29, 2019)
  • K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCP (January 5, 2018)
  • K171330 — Nanova Sealant (September 8, 2017)
  • K162598 — HAPI Seal (May 23, 2017)
  • K161580 — Premier Sealant (October 18, 2016)
  • K141717 — PACSEAL PIT & FISSURE SEALANT (March 9, 2015)
  • K130485 — CONTROL SEAL (February 11, 2014)