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K Number
K003640
Device Name
MINIENDO III
Manufacturer
SYBRON DENTAL SPECIALTIES, INC.
Date Cleared
2001-02-22

(87 days)

Product Code
ELB
Regulation Number
872.4840
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 872.4840 Rotary scaler.

(a)
Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy.(b)
Classification. Class II.