| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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053
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Date of Entry 12/23/2019
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FR Recognition Number
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8-492
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| Standard | |
| ISO 5832-9 Third edition 2019-02 Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel |
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Scope/AbstractThis document specifies the characteristics of, and corresponding test methods for, wrought stainless steel containing a mass fraction of 0,25 % to 0,50 % nitrogen for use in the manufacture of surgical implants for which high levels of strength and corrosion resistance are required.
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
NOTE 2 Requirements for other stainless steels for implants for surgery can be found in ISO 5832-1.
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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. |
|
Transition Period
| FDA recognition of ISO 5832-9 Second edition 2007-06-15 [Rec# 8-150] will be superseded by recognition of ISO 5832-9 Third edition 2019-02 [Rec# 8-492]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-150] until July 24, 2022. After this transition period, declarations of conformity to [Rec# 8-150] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §872.3130 |
Anchor, Preformed |
Class 1 |
EJX |
| Metallic components of all implantables |
| No product code information listed for §888.3XXX, Metallic components of all implantables |
| §872.3165 |
Attachment, Precision, All |
Class 1 |
EGG |
| §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 |
| §872.4120 |
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 |
| §872.4565 |
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 |
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, Periodontic |
Class 1 |
EMR |
| §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 |
Lapping Tool Kit |
Class 1 |
NYG |
| §872.4565 |
Marker, Periodontic |
Class 1 |
EMP |
| §872.4565 |
Mirror, Mouth |
Class 1 |
EAX |
| §872.4565 |
Parallelometer |
Class 1 |
EGI |
| §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, Irrigating (Dental) |
Class 1 |
EIB |
| §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 |
| §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 |
Bracket, Metal, Orthodontic |
Class 1 |
EJF |
| §872.5410 |
Bracket, Metal, Orthodontic, Reprocessed |
Class 1 |
NQS |
| §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 |
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| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
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| *These are provided as examples and others may be applicable. |
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