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510(k) K905582

POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND by Milton Hodosh, M.D. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1991
Date Received
December 12, 1990
Clearance Type
Traditional
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 Milton Hodosh, M.D.

  • K032175 — DESENS-IONOMER (October 9, 2003)
  • K031721 — COMPOSITE RESTORATION MATERIAL (September 11, 2003)
  • K022025 — MODIFICATION TO POTASSIUM NITRATE-POLYCARBOXYLATE DENTAL CEMENT (August 15, 2002)
  • K925207 — GLASS IONOMER CEMENT (July 8, 1993)
  • K895988 — POTASSIUM NITRATE-ZINC OXIDE EUGENOL TEMP. DENTAL (March 7, 1990)
  • K882417 — POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT (February 13, 1989)

Other clearances for product code EBC

  • K243254 — Parkell Pit and Fissure Sealant (August 8, 2025)
  • 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)