ETCHING GEL

K810266 · Espe-Premier Sales Co. · EJK · Feb 23, 1981 · Dental

Device Facts

Record IDK810266
Device NameETCHING GEL
ApplicantEspe-Premier Sales Co.
Product CodeEJK · Dental
Decision DateFeb 23, 1981
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.3250
Device ClassClass 2

Regulatory Classification

Identification

A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.

Innolitics

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