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EBC — Sealant, Pit And Fissure, And Conditioner Class II

FDA Device Classification

FDA product code EBC covers "Sealant, Pit And Fissure, And Conditioner", a Class II medical device regulated under 21 CFR 872.3765. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
EBC
Device Class
Class II
Regulation Number
872.3765
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K260819mediclus coAny-Com SealMay 1, 2026
K243254parkellParkell Pit and Fissure SealantAugust 8, 2025
K232498ultradent productUltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection bAugust 18, 2023
K230455rizhao huge biomaterials companyEnamel Coating ResinJuly 25, 2023
K190998apex dental materialsBA Pit & Fissure SealantNovember 8, 2019
K190339ivoclar vivadentHelioseal F PlusJuly 29, 2019
K172169pulpdent corporationPulpdent (Activa) Pit and Fissure Sealant with MCPJanuary 5, 2018
K171330nanova biomaterialsNanova SealantSeptember 8, 2017
K162598biscoHAPI SealMay 23, 2017
K161580premier dental company productsPremier SealantOctober 18, 2016
K141717pac-dent internationalPACSEAL PIT & FISSURE SEALANTMarch 9, 2015
K130485vocoCONTROL SEALFebruary 11, 2014
K122521itena clinicalPREVENT SEALJune 11, 2013
K113818pulpdent corporationEMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILLMarch 21, 2012
K112517ultradent productsULTRASEAL XT HYDROSeptember 23, 2011
K111782shofu dental corporationBEAUTISEALANTSeptember 16, 2011
K110058novocol inc. dba septodont and confi-dental producBPA-FREE PIT AND FISSURE SEALANTMarch 31, 2011
K102252dmpDMP PIT & FISSURE SEALANTDecember 3, 2010
K103121vericom coECO-SOctober 26, 2010
K101245ultradent productsULTRASEAL IDSeptember 17, 2010

FDA data resources