Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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056
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Date of Entry 06/07/2021
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FR Recognition Number
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4-281
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Standard | |
ISO 1797 Third Edition 2017-05 Dentistry - Shanks for rotary and oscillating instruments |
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Identical AdoptionANSI ADA Standard No. 179-2020 Shanks for Rotary and Oscillating Instruments |
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Scope/AbstractISO 1797:2017 specifies the requirements for dimensions and material properties of shanks used in dentistry for rotary or oscillating instruments. It describes the measurement methods for the verification of the requirements.
ISO 1797:2017 is not applicable to tips fixed to the handpiece with a screw, e.g. scaler tips.
Information about the location of marking is also given. Annex A on quality control is included in order to ensure a high quality level. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.3240 |
Bur, Dental
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Class 1
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EJL
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§872.3240 |
Bur, Diamond Coated, Reprocessed
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Class 1
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NME
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§872.4120 |
Saw, Bone, Ac-Powered
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Class 2
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DZH
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§872.4120 |
Drill, Bone, Powered
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Class 2
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DZI
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§872.4120 |
Driver, Wire, And Bone Drill, Manual
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Class 2
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DZJ
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§872.4120 |
Handpiece, Rotary Bone Cutting
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Class 2
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KMW
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§872.4200 |
Controller, Foot, Handpiece And Cord
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Class 1
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EBW
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§872.4200 |
Handpiece, Belt And/Or Gear Driven, Dental
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Class 1
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EFA
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§872.4200 |
Handpiece, Air-Powered, Dental
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Class 1
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EFB
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§872.4200 |
Handpiece, Contra- And Right-Angle Attachment, Dental
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Class 1
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EGS
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§872.4200 |
Handpiece, Direct Drive, Ac-Powered
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Class 1
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EKX
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§872.4200 |
Handpiece, Water-Powered
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Class 1
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EKY
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§872.4200 |
Handpiece, Air-Powered, Root Canal Irrigation
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Class 1
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NYL
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§872.4840 |
Scaler, Rotary
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Class 2
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ELB
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§872.6640 |
Unit, Operative Dental
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Class 1
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EIA
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Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions, Issued May 2007.
2. Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Issued March 2015.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |