| ISO 8325 Second edition 2004-09-15 Dentistry - Test methods for rotary instruments |
| Recognition Number | Dental/ENT |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 4-244 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
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 specifies methods for measuring the dimensional characteristics, neck strength and surface roughness of dental rotary instruments, such as burs, cutters, polishers, diamond and abrasive instruments.
This International Standard does not provide test methods for the characteristics of materials used for dental rotary instruments.
NOTE For testing of these characteristics, see the respective product standards.
This International Standard is not applicable to dental root-canal instruments (see ISO 3630-1).
| Regulation Number | Device Name | Device Class | Product Code |
| §872.6640 | Unit, Operative Dental | Class 1 | EIA |
| §872.4535 | Instrument, Diamond, Dental | Class 1 | DZP |
| §872.4535 | Instrument, Diamond, Dental, Reprocessed | Class 1 | NLD |
| §872.4200 | Controller, Foot, Handpiece And Cord | Class 1 | EBW |
| §872.4200 | Handpiece, Air-Powered, Dental | Class 1 | EFB |
| §872.4200 | Handpiece, Air-Powered, Root Canal Irrigation | Class 1 | NYL |
| §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 | Dental Stereotaxic Instrument | Class 2 | PLV |
| §872.4120 | Drill, Bone, Powered | Class 2 | DZI |
| §872.4120 | Driver, Wire, And Bone Drill, Manual | Class 2 | DZJ |
| §872.4120 | Handpiece, Rotary Bone Cutting | Class 2 | KMW |
| §872.4120 | Saw, Bone, Ac-Powered | Class 2 | DZH |
| §872.3240 | Bur, Dental | Class 1 | EJL |
| §872.3240 | Bur, Diamond Coated, Reprocessed | Class 1 | NME |
| Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions, Issued May 2007. |