K Number
K954790Device Name
PROFILE NICKEL TITANIUM ROTARY INSTRUMENTSManufacturer
Date Cleared
1996-01-16
(89 days)
Product Code
Regulation Number
872.4130Type
TraditionalPanel
DentalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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§ 872.4130 Intraoral dental drill.
(a)
Identification. An intraoral dental drill is a rotary device intended to be attached to a dental handpiece to drill holes in teeth to secure cast or preformed pins to retain operative dental appliances.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.