SATALEC PIEZOTEC

K852525 · Spelna, Inc. · ELC · Jan 30, 1986 · Dental

Device Facts

Record IDK852525
Device NameSATALEC PIEZOTEC
ApplicantSpelna, Inc.
Product CodeELC · Dental
Decision DateJan 30, 1986
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.4850
Device ClassClass 2

Regulatory Classification

Identification

An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Innolitics

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