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510(k) K113818

EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL by Pulpdent Corporation — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2012
Date Received
December 27, 2011
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

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  • K123265 — RMGI LOW VISCOSITY (December 7, 2012)
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  • K120003 — NUCAL (April 5, 2012)
  • K120213 — ETCH-RITE SUPREME (March 30, 2012)
  • K113711 — LIME-LITE II (March 5, 2012)

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  • K162598 — HAPI Seal (May 23, 2017)
  • K161580 — Premier Sealant (October 18, 2016)
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