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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 8-350: ISO 5832-1 Fourth edition 2007-06-15, implants for surgery -- metallic materials -- part 1: wrought stainless steel [including: technical corrigendum 1 (2008)]. (Materials)

Date of Standard: 2007. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Implantable Medical Devices
Processes Affected:
510(K), PMA, IDE, PDP, HDE, Design Controls
Type of Standard:
 Horizontal, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§872.3130 Anchor, Preformed Class 1 EJX
§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 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
§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
No product code information listed for §888.3XXX, Metallic components of all implantables
FDA Technical Contacts:
 John Goode (Orthopaedics)
  FDA/CDRH/ODE/DGRND
  9200 CORPORATE BLVD, HFZ-410
  ROCKVILLE MD 20850
  240/276-3676
  email: JOHN.GOODE@FDA.HHS.GOV
 Michael J. Ryan (Dental)
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 1615
  Silver Spring MD 20993
  301/796-6283
  email: michael.ryan@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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