HYBRID POINTS

K854347 · Shofu Dental Corp. · DZP · Dec 27, 1985 · Dental

Device Facts

Record IDK854347
Device NameHYBRID POINTS
ApplicantShofu Dental Corp.
Product CodeDZP · Dental
Decision DateDec 27, 1985
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.4535
Device ClassClass 1

Regulatory Classification

Identification

A dental diamond instrument is an abrasive device intended to smooth tooth surfaces during the fitting of crowns or bridges. The device consists of a shaft which is inserted into a handpiece and a head which has diamond chips imbedded into it. Rotation of the diamond instrument provides an abrasive action when it contacts a tooth.

Innolitics

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