Skip to content

Henry Schein Canister Handpiece

by Handpiece Headquarters, Inc. - Hpr, Inc. EUDAMED510(k)

Active European Union and United States

510(k) K080682

Overview

The Henry Schein Canister Handpiece is an air-powered, dental handpiece designed for cavity preparation and cleaning in restorative dentistry. It is a handheld device intended for preparing dental cavities for restorations, such as fillings, and for cleaning procedures. The device may include a contra-angle attachment for accessing difficult-to-reach areas in the oral cavity.

This device is a reusable, air-powered handpiece intended for use in dental settings. It is classified under FDA regulation 872.4200 as a Class I device, with an FDA 510(k) clearance and MDR authorization. The handpiece is designed for single-user applications and adheres to standard dental instrument protocols for sterility and maintenance. No specific MRI safety information is provided.

Henry Schein Canister Handpiece

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Abbreviated NumberK080682 Date11 Sep 2008ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k)

Full name
Hhc, Score, Henry Schein Canister Handpiece
510(k) Number
FDA Product Code
EFB
Device Class
Class I
Regulation
21 CFR Part 872.4200
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Handpiece Headquarters

See all devices from Handpiece Headquarters →

Questions

  • What is the Henry Schein Canister Handpiece used for in dental procedures?

    The Henry Schein Canister Handpiece is designed specifically for cavity preparation and cleaning in restorative dentistry. It helps prepare dental cavities for restorations like fillings and aids in cleaning procedures. The device can also include a contra-angle attachment, allowing access to difficult-to-reach areas in the oral cavity, such as deep or angled cavities.

  • Is the Henry Schein Canister Handpiece reusable or single-use?

    This handpiece is a reusable device, intended for single-user applications within dental settings. It follows standard dental instrument protocols for sterility and maintenance, ensuring safe and hygienic use across multiple procedures as long as proper cleaning and disinfection procedures are followed.

  • How is sterility maintained for the Henry Schein Canister Handpiece?

    The handpiece adheres to standard dental instrument protocols for sterility. While it is reusable, it must be thoroughly cleaned, disinfected, and sterilized between uses to prevent cross-contamination. Dental professionals should follow established guidelines for instrument reprocessing to ensure compliance with infection control standards.

  • Does the Henry Schein Canister Handpiece come with any attachments?

    Yes, the Henry Schein Canister Handpiece may include a contra-angle attachment as part of its design. This attachment allows for greater versatility in accessing difficult-to-reach areas in the oral cavity, making it useful for procedures that require angled or deep cavity preparation.

  • What regulatory approvals does the Henry Schein Canister Handpiece have?

    The device holds FDA 510(k) clearance and MDR authorization, confirming its compliance with regulatory standards for dental handpieces. It is classified under FDA regulation 872.4200 as a Class I device, indicating it poses minimal risk and has undergone evaluation for safety and performance.