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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 046 Date of Entry 12/23/2016 
FR Recognition Number 8-435
Standard
ISO 5832-1 Fifth edition 2016-07-15 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
Scope/Abstract
This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.

NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832.

NOTE 2 The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.
Extent of Recognition
Complete standard
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
§872.3285 Clasp, Preformed Class 1 EHP
§872.3330 Crown, Preformed Class 1 ELZ
§872.3350 Cusp, Gold And Stainless Steel Class 1 ELO
§872.3360 Cusp, Preformed Class 1 EHQ
§872.3580 Teeth, Preformed Gold Denture Class 1 ELN
§872.3740 Pin, Retentive And Splinting, And Accessory Instruments Class 1 EBL
§872.3810 Post, Root Canal Class 1 ELR
§872.3900 Teeth, Artificial, Posterior With Metal Insert Class 1 ELJ
§872.3130 Anchor, Preformed Class 1 EJX
§872.3165 Attachment, Precision, All Class 1 EGG
§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
§872.4130 Drill, Dental, Intraoral Class 1 DZA
§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
§872.4600 Lock, Wire, And Ligature, Intraoral Class 2 DYX
§872.4760 External Mandibular Fixator And/Or Distractor Class 2 MQN
§872.4760 Implant, Transmandibular Class 2 MDL
§872.4760 Plate, Bone Class 2 JEY
§872.4880 Screw, Fixation, Intraosseous Class 2 DZL
§872.5410 Band, Elastic, Orthodontic Class 1 ECI
§872.5410 Band, Material, Orthodontic Class 1 DYO
§872.5410 Band, Preformed, Orthodontic Class 1 ECM
§872.5410 Clamp, Wire, Orthodontic Class 1 ECN
§872.5410 Retainer, Screw Expansion, Orthodontic Class 1 DYJ
§872.5410 Spring, Orthodontic Class 1 ECO
§872.5410 Tube, Orthodontic Class 1 DZD
§872.5410 Wire, Orthodontic Class 1 DZC
§872.5500 Headgear, Extraoral, Orthodontic Class 2 DZB
Metallic components of all implantables
No product code information listed for §888.3XXX, Metallic components of all implantables
§872.4565 Accessories, Retractor, Dental Class 1 EIF
§872.4565 Aligner, Bracket, Orthodontic Class 1 ECQ
§872.4565 Broach, Endodontic Class 1 EKW
§872.4565 Burnisher, Operative Class 1 EKJ
§872.4565 Carrier, Amalgam, Operative Class 1 EKI
§872.4565 Carver, Dental Amalgam, Operative Class 1 EKH
§872.4565 Carver, Wax, Dental Class 1 EIK
§872.4565 Chisel, Bone, Surgical Class 1 EML
§872.4565 Chisel, Osteotome, Surgical Class 1 EMM
§872.4565 Condenser, Amalgam And Foil, Operative Class 1 EKG
§872.4565 Curette, Endodontic Class 1 EKT
§872.4565 Curette, Operative Class 1 EKE
§872.4565 Curette, Periodontic Class 1 EMS
§872.4565 Curette, Surgical, Dental Class 1 EMK
§872.4565 Driver, Band, Orthodontic Class 1 ECT
§872.4565 Elevator, Surgical, Dental Class 1 EMJ
§872.4565 Excavator, Dental, Operative Class 1 EKC
§872.4565 Explorer, Operative Class 1 EKB
§872.4565 File, Bone, Surgical Class 1 EMI
§872.4565 File, Margin Finishing, Operative Class 1 EKA
§872.4565 File, Pulp Canal, Endodontic Class 1 EKS
§872.4565 Forceps, Articulation Paper Class 1 EFK
§872.4565 Forceps, Dressing, Dental Class 1 EFL
§872.4565 Forceps, Rongeur, Surgical Class 1 EMH
§872.4565 Forceps, Tooth Extractor, Surgical Class 1 EMG
§872.4565 Gauge, Depth, Instrument, Dental Class 1 EIL
§872.4565 Handle, Instrument, Dental Class 1 EJB
§872.4565 Hemostat, Surgical Class 1 EMD
§872.4565 Hoe, Periodontic Class 1 EMQ
§872.4565 Instrument, Contouring, Matrix, Operative Class 1 EKF
§872.4565 Instrument, Cutting, Operative Class 1 EKD
§872.4565 Instrument, Filling, Plastic, Dental Class 1 EIY
§872.4565 Instrument, Hand, Calculus Removal Class 1 ELA
§872.4565 Instrument, Ligature Tucking, Orthodontic Class 1 ECP
§872.4565 Instruments, Dental Hand Class 1 DZN
§872.4565 Knife, Margin Finishing, Operative Class 1 EJZ
§872.4565 Knife, Periodontic Class 1 EMO
§872.4565 Marker, Periodontic Class 1 EMP
§872.4565 Mirror, Mouth Class 1 EAX
§872.4565 Plier, Orthodontic Class 1 JEX
§872.4565 Pliers, Operative Class 1 EJY
§872.4565 Plugger, Root Canal, Endodontic Class 1 EKR
§872.4565 Preparer, Root Canal Endodontic Class 1 EKQ
§872.4565 Probe, Periodontic Class 1 EIX
§872.4565 Punch, Biopsy, Surgical Class 1 EME
§872.4565 Pusher, Band, Orthodontic Class 1 ECS
§872.4565 Reamer, Pulp Canal, Endodontic Class 1 EKP
§872.4565 Remover, Crown Class 1 EIS
§872.4565 Retainer, Matrix Class 1 JEP
§872.4565 Retractor, All Types Class 1 EIG
§872.4565 Scaler, Periodontic Class 1 EMN
§872.4565 Scissors, Collar And Crown Class 1 EIR
§872.4565 Scissors, Surgical Tissue, Dental Class 1 EGN
§872.4565 Setter, Band, Orthodontic Class 1 ECR
§872.4565 Spreader, Pulp Canal Filling Material, Endodontic Class 1 EKK
§872.4565 Syringe, Periodontic, Endodontic, Irrigating Class 1 EIC
§872.4565 Syringe, Restorative And Impression Material Class 1 EID
§872.4565 Unit, Syringe, Air And/Or Water Class 1 ECB
FDA Technical Contacts
 John Goode
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIA/
  301-796-6407
  john.goode@fda.hhs.gov
 Michael J. Ryan
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-6283
  michael.ryan@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
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