LogoFDA 510(k) Search
K Number
K082716
Device Name
A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43
Manufacturer
A-DEC, INC.
Date Cleared
2009-01-15

(120 days)

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

The A-dec/W&H Alegra Air-Driven Highspeed Handpiece is an air-powered dental device. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

The A-dec/W&H Alegra Handpiece Attachment is powered by either an air-motor or electric motor and is intended for use in general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) clearance letter from the FDA for a dental handpiece, indicating that the device has been found substantially equivalent to a legally marketed predicate device. This type of clearance focuses on demonstrating equivalence rather than presenting specific performance study results against predefined acceptance criteria.

The document contains:

  • Device Information: Trade/Device Name, Regulation Number, Regulation Name, Regulatory Class, Product Code.
  • FDA Clearance Details: Confirmation of substantial equivalence, general controls provisions, and contact information for various FDA departments.
  • Indications For Use: A description of how the dental handpiece is intended to be used (e.g., removing carious material, cavity and crown preparation).

Therefore, I cannot provide the requested table or answer the other questions because the necessary information is not present in the provided text.

§ 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.