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K Number
K103158
Device Name
STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER
Manufacturer
ANGSTROM MFG., INC.
Date Cleared
2011-02-07

(104 days)

Product Code
EGS
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This Device is to be used by a Dental Hygienist for cleaning procedures on teeth. For the coupling of Disposable Prophy Angles to Dental Handpiece motors.
Prescription Use: Used by dental Professional Only
Over the Counter Use: No

Device Description

DPA Attachment Twist/Flex Adapter

AI/ML Overview

I am sorry but this document is a 510(k) clearance letter from the FDA for a dental device (DPA Attachment Twist/Flex Adapter). It primarily addresses the regulatory approval process and includes an "Indications for Use" statement.

I am unable to find the requested information in the document provided, in particular there is no mention of:

  1. Acceptance criteria or device performance results.
  2. Details on sample sizes, data provenance, or ground truth establishment for any studies.
  3. Information on expert involvement, adjudication methods, or multi-reader multi-case studies.
  4. An effect size of how much human readers improve with AI vs without AI assistance.

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.