| ISO 9168 Third edition 2009-07-15 Dentistry - Hose connectors for air driven dental handpieces |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 4-180 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
| FDA Tech | Sheena Green FDA/OMPT/CDRH/OC/DBM/BCB II/ 301-796-6279 sheena.green@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This International Standard is applicable for achieving reliable interchangeability between hoses from dental units and dental handpieces.
This International Standard specifies four types of hose connector for use between air driven dental handpieces and the flexible hoses of the dental unit which supply the handpieces with water, air and light, and provide for exhaust.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.6640 | Unit, Operative Dental | Class 1 | EIA |
| §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 |
| §872.4120 | Handpiece, Rotary Bone Cutting | Class 2 | KMW |
| Guidance for Industry and FDA Staff Dental Handpieces - Premarket Notification [510(k)] Submissions Document issued on: May 2, 2007. |