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Product Classification

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Device

handpiece, contra- and right-angle attachment, dental

Regulation Description

Dental handpiece and accessories.

Regulation Medical Specialty

Dental

Review Panel

Dental

Product Code

EGS

Premarket Review

Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)

Submission Type

510(k)

Regulation Number

872.4200

Device Class

1

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Summary Malfunction
Reporting

Ineligible

Implanted Device?

No

Life-Sustain/Support Device?

No

Recognized Consensus Standards

4-180 ISO 9168 Third edition 2009-07-15
Dentistry - Hose connectors for air driven dental handpieces
4-244 ISO 8325 Second edition 2004-09-15
Dentistry - Test methods for rotary instruments
4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
4-262 IEC 80601-2-60 Edition 2.0 2019-06
Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
4-269 ISO 3964 Third edition 11-2016
Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
4-276 ISO 14457 Second edition 2017-10
Dentistry - Handpieces and motors
4-281 ISO 1797 Third Edition 2017-05
Dentistry - Shanks for rotary and oscillating instruments
4-305 ISO 10637 Second edition 2018-05
Dentistry - Central suction source equipment
4-306 ISO 22052 First edition 2020-06
Dentistry - Compressed air source equipment
4-317 ISO 8325 Third edition 2023-03
Dentistry - Test methods for rotary instruments

Guidance Document

Guidance Document on Dental Handpieces

Third Party Review

Eligible for 510(k) Third Party Review Program

Accredited Persons

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