Recognized Consensus Standards

Recognition List Number: 028 Publication Date: 03/16/2012

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 4-83: ISO 11498 First edition 1997-02-15, Dental handpieces: Dental low-voltage electrical motors. (Dental/ENT)

Date of Standard: 1997.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Offices and Divisions Associated with Recognized Standards:

(1)	OFFICE OF DEVICE EVALUATION (ODE)

(2)	OFFICE OF COMPLIANCE (OC)

Devices Affected:

Low voltage electric motors used with handpieces

Processes Affected:

510(k), PMA, IDE, HDE, PDP, Design Control, Quality System Regulations

Type of Standard:

Vertical, International

Extent of Recognition:

Complete Standard. Data from the test methods in the standard is needed. Additional testing may be necessary for some products.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§872.4120	Handpiece, Rotary Bone Cutting	Class 2	KMW

Regulation Number	Device Name	Device Class	Product Code
§872.4200	Controller, Foot, Handpiece And Cord	Class 1	EBW
§872.4200	Handpiece, Air-Powered, Dental	Class 1	EFB
§872.4200	Handpiece, Belt And/Or Gear Driven, Dental	Class 1	EFA
§872.4200	Handpiece, Contra- And Right-Angle Attachment, Dental	Class 1	EGS
§872.4200	Handpiece, Direct Drive, Ac-Powered	Class 1	EKX
§872.4200	Handpiece, Water-Powered	Class 1	EKY