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KLE — Agent, Tooth Bonding, Resin Class II

FDA Device Classification

Classification Details

Product Code
KLE
Device Class
Class II
Regulation Number
872.3200
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252450ivoclar vivadentAdhese 2March 5, 2026
K260682premier dental productsBond-PR™ Universal AdhesiveMarch 3, 2026
K251587vita zahnfabrik h. rauter gmbh and co. kgVITA VMLC PrimerFebruary 23, 2026
K252151saremco dentalels unibondDecember 5, 2025
K252469dmp dental industryMAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCANovember 6, 2025
K251124gc americaG-Bond UniversalOctober 2, 2025
K242530rizhao huge biomaterials companyHF-Etchant Hydrofluoric Acid Etching GelDecember 20, 2024
K242749rizhao huge biomaterials companyTopCEM Ceramic Primer Ceramic Coupling AgentNovember 8, 2024
K242675spident coFineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml,November 1, 2024
K240153liaoning upcera coCeramic Etchant (HF-5 and HF-9)October 2, 2024
K241445spident coK-Bond UniversalJuly 22, 2024
K241056sincera technology (changchun) coLight Cure AdhesiveJuly 16, 2024
K240743ultradent productsPeak Universal BondMarch 20, 2024
K231039kuraray noritake dentalCLEARFIL Universal Bond Quick 2December 13, 2023
K232978sino-dentex coDX. Bond V Dental Bonding AdhesiveSeptember 22, 2023
K231696prevest denpro limitedFusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalAugust 11, 2023
K230465mediclus coHi-Bond UniversalMay 22, 2023
K230009meta biomed coEZ Bond UniversalMarch 3, 2023
K222830kerr corporationRainbow 360January 12, 2023
K221450rizhao huge biomaterials companyPhosphoric Acid Etching GelSeptember 12, 2022