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510(k) K103121

ECO-S by Vericom Co., Ltd. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2010
Date Received
October 22, 2010
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

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Other clearances for product code EBC

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  • 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)