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510(k) K243254

Parkell Pit and Fissure Sealant by Parkell, Inc. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2025
Date Received
October 15, 2024
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

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 Parkell, Inc.

  • K210259 — Parkell Self-Adhesive Cement (January 20, 2022)
  • K191103 — Parkell Desensitizer Gel (November 22, 2019)
  • K190930 — SmarTemp X1 (September 5, 2019)
  • K182296 — HyperFil-LV (December 14, 2018)
  • K172176 — Parkell Universal Adhesive (November 21, 2017)
  • K151518 — BRUSH&BOND PLUS (September 18, 2015)
  • K142848 — EAZY PRIMER (February 24, 2015)
  • K132115 — ABSOLUTE DENTIN 2 (June 25, 2014)
  • K113839 — RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE (April 12, 2012)
  • K101044 — RETRIEVE IMPLANT CEMENT (June 10, 2010)

Other clearances for product code EBC

  • K232498 — UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection b (August 18, 2023)
  • K230455 — Enamel Coating Resin (July 25, 2023)
  • K190998 — BA Pit & Fissure Sealant (November 8, 2019)
  • 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)