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510(k) K760405

SEALANT, NEW FILLED by L.D. Caulk Co. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1976
Date Received
August 9, 1976
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 L.D. Caulk Co.

  • K802262 — COMPOSITE RESTORATIVE (September 16, 1980)
  • K801690 — VALIANT (August 13, 1980)
  • K790586 — CHEMBOND (May 16, 1979)
  • K790585 — FINESSE (May 16, 1979)
  • K780560 — DENTAL AMALGAMATOR (April 21, 1978)
  • K780384 — IMPROVED DYCAL (March 15, 1978)
  • K780301 — CAULK TYLOK (February 28, 1978)
  • K771398 — SHELL VENEER (August 26, 1977)
  • K771402 — NUVA-COTE (MODIFICATION TO) (August 26, 1977)
  • K771399 — LIP & CHEEK RETRACTOR (August 26, 1977)

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)