| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
066
|
Date of Entry 05/25/2026
|
|
FR Recognition Number
|
4-395
|
| Standard | |
ISO 21850-1 First edition 2020-04
Dentistry - Materials for dental instruments - Part 1: Stainless steel |
|
Identical AdoptionANSI ADA Standard No. 196-2021
Materials for Dental Instruments - Part 1: Stainless Steel |
|
Scope/AbstractThis document specifies stainless steel commonly used in manufacturing dental instruments.
It is applicable to stainless steel materials used to manufacture either an entire instrument or a part of the instrument.
It is applicable to single-use and reusable dental instruments, whether it is or it is not connected to a power-driven system.
This document is not applicable to devices and instruments used long-term in the mouth of the patient (e.g. crown, bridges, implants) or to devices and instruments not made of stainless steel.
It contains a current selection of stainless steels suitable for use in the manufacture of dental instruments. |
|
| Extent of Recognition
|
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. |
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.3240 |
Bur, Dental
|
Class 1
|
EJL
|
| §872.3670 |
Material, Impression Tray, Resin
|
Class 1
|
EBH
|
| §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
|
| §872.4565 |
Instruments, Dental Hand
|
Class 1
|
DZN
|
| §872.4565 |
Unit, Syringe, Air And/Or Water
|
Class 1
|
ECB
|
| §872.4565 |
Instrument, Ligature Tucking, Orthodontic
|
Class 1
|
ECP
|
| §872.4565 |
Setter, Band, Orthodontic
|
Class 1
|
ECR
|
| §872.4565 |
Pusher, Band, Orthodontic
|
Class 1
|
ECS
|
| §872.4565 |
Driver, Band, Orthodontic
|
Class 1
|
ECT
|
| §872.4565 |
Forceps, Articulation Paper
|
Class 1
|
EFK
|
| §872.4565 |
Forceps, Dressing, Dental
|
Class 1
|
EFL
|
| §872.4565 |
Parallelometer
|
Class 1
|
EGI
|
| §872.4565 |
Scissors, Surgical Tissue, Dental
|
Class 1
|
EGN
|
| §872.4565 |
Syringe, Irrigating (Dental)
|
Class 1
|
EIB
|
| §872.4565 |
Syringe, Restorative And Impression Material
|
Class 1
|
EID
|
| §872.4565 |
Accessories, Retractor, Dental
|
Class 1
|
EIF
|
| §872.4565 |
Retractor, All Types
|
Class 1
|
EIG
|
| §872.4565 |
Carver, Wax, Dental
|
Class 1
|
EIK
|
| §872.4565 |
Gauge, Depth, Instrument, Dental
|
Class 1
|
EIL
|
| §872.4565 |
Scissors, Collar And Crown
|
Class 1
|
EIR
|
| §872.4565 |
Remover, Crown
|
Class 1
|
EIS
|
| §872.4565 |
Probe, Periodontic
|
Class 1
|
EIX
|
| §872.4565 |
Instrument, Filling, Plastic, Dental
|
Class 1
|
EIY
|
| §872.4565 |
Pliers, Operative
|
Class 1
|
EJY
|
| §872.4565 |
File, Margin Finishing, Operative
|
Class 1
|
EKA
|
| §872.4565 |
Explorer, Operative
|
Class 1
|
EKB
|
| §872.4565 |
Excavator, Dental, Operative
|
Class 1
|
EKC
|
| §872.4565 |
Instrument, Cutting, Operative
|
Class 1
|
EKD
|
| §872.4565 |
Curette, Operative
|
Class 1
|
EKE
|
| §872.4565 |
Instrument, Contouring, Matrix, Operative
|
Class 1
|
EKF
|
| §872.4565 |
Condenser, Amalgam And Foil, Operative
|
Class 1
|
EKG
|
| §872.4565 |
Carver, Dental Amalgam, Operative
|
Class 1
|
EKH
|
| §872.4565 |
Carrier, Amalgam, Operative
|
Class 1
|
EKI
|
| §872.4565 |
Burnisher, Operative
|
Class 1
|
EKJ
|
| §872.4565 |
Spreader, Pulp Canal Filling Material, Endodontic
|
Class 1
|
EKK
|
| §872.4565 |
Reamer, Pulp Canal, Endodontic
|
Class 1
|
EKP
|
| §872.4565 |
Preparer, Root Canal Endodontic
|
Class 1
|
EKQ
|
| §872.4565 |
Plugger, Root Canal, Endodontic
|
Class 1
|
EKR
|
| §872.4565 |
File, Pulp Canal, Endodontic
|
Class 1
|
EKS
|
| §872.4565 |
Curette, Endodontic
|
Class 1
|
EKT
|
| §872.4565 |
Broach, Endodontic
|
Class 1
|
EKW
|
| §872.4565 |
Instrument, Hand, Calculus Removal
|
Class 1
|
ELA
|
| §872.4565 |
Hemostat, Surgical
|
Class 1
|
EMD
|
| §872.4565 |
Punch, Biopsy, Surgical
|
Class 1
|
EME
|
| §872.4565 |
Forceps, Tooth Extractor, Surgical
|
Class 1
|
EMG
|
| §872.4565 |
Forceps, Rongeur, Surgical
|
Class 1
|
EMH
|
| §872.4565 |
File, Bone, Surgical
|
Class 1
|
EMI
|
| §872.4565 |
Elevator, Surgical, Dental
|
Class 1
|
EMJ
|
| §872.4565 |
Curette, Surgical, Dental
|
Class 1
|
EMK
|
| §872.4565 |
Chisel, Bone, Surgical
|
Class 1
|
EML
|
| §872.4565 |
Chisel, Osteotome, Surgical
|
Class 1
|
EMM
|
| §872.4565 |
Scaler, Periodontic
|
Class 1
|
EMN
|
| §872.4565 |
Knife, Periodontic
|
Class 1
|
EMO
|
| §872.4565 |
Marker, Periodontic
|
Class 1
|
EMP
|
| §872.4565 |
Hoe, Periodontic
|
Class 1
|
EMQ
|
| §872.4565 |
File, Periodontic
|
Class 1
|
EMR
|
| §872.4565 |
Curette, Periodontic
|
Class 1
|
EMS
|
| §872.4565 |
Retainer, Matrix
|
Class 1
|
JEP
|
| §872.4565 |
Plier, Orthodontic
|
Class 1
|
JEX
|
| §872.4565 |
Dental Prophylaxis Kit
|
Class 1
|
NYC
|
| §872.4565 |
Gingival Retraction Kit
|
Class 1
|
NYF
|
| §872.4565 |
Lapping Tool Kit
|
Class 1
|
NYG
|
| §872.6300 |
Clamp, Rubber Dam
|
Class 1
|
EEF
|
| §872.6300 |
Dam, Rubber
|
Class 1
|
EIE
|
| §872.6300 |
Frame, Rubber Dam
|
Class 1
|
EJE
|
| §872.6300 |
Forceps, Rubber Dam Clamp
|
Class 1
|
EJG
|
| §872.6880 |
Tray, Impression, Preformed
|
Class 1
|
EHY
|
|
Relevant FDA Guidance and/or Supportive Publications*
| Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
|
|
