| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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050
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Date of Entry 09/17/2018
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|
FR Recognition Number
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4-244
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| Standard | |
ISO 8325 Second edition 2004-09-15
Dentistry - Test methods for rotary instruments |
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Scope/AbstractThis 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). |
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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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Transition Period
| FDA recognition of ISO 8325 Second edition 2004-09 [Rec# 4-244] will be superseded by recognition of ISO 8325 Third edition 2023-03 [Rec# 4-317]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 4-244] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 4-244] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.3240 |
Bur, Dental
|
Class 1
|
EJL
|
| §872.3240 |
Bur, Diamond Coated, Reprocessed
|
Class 1
|
NME
|
| §872.4120 |
Saw, Bone, Ac-Powered
|
Class 2
|
DZH
|
| §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 |
Dental Stereotaxic Instrument
|
Class 2
|
PLV
|
| §872.4200 |
Controller, Foot, Handpiece And Cord
|
Class 1
|
EBW
|
| §872.4200 |
Handpiece, Belt And/Or Gear Driven, Dental
|
Class 1
|
EFA
|
| §872.4200 |
Handpiece, Air-Powered, Dental
|
Class 1
|
EFB
|
| §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
|
| §872.4200 |
Handpiece, Air-Powered, Root Canal Irrigation
|
Class 1
|
NYL
|
| §872.4535 |
Instrument, Diamond, Dental
|
Class 1
|
DZP
|
| §872.4535 |
Instrument, Diamond, Dental, Reprocessed
|
Class 1
|
NLD
|
| §872.6640 |
Unit, Operative Dental
|
Class 1
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EIA
|
|
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. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff, 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. |
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