Product Classification

• Device: handpiece, direct drive, ac-powered
• Regulation Description: Dental handpiece and accessories.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: EKX
• Submission Type: 510(k)
• Regulation Number: 872.4200
• Device Class: 1
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 7785-2 Second edition 1995-08-01 Dental handpieces -- Part 2: Straight and geared angle handpieces
• ISO 11498 First edition 1997-02-15 Dental handpieces: Dental low-voltage electrical motors
• ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces

Guidance Document

• Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.