Recognized Consensus Standards

Recognition List Number: 020 Publication Date: 09/09/2008

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 8-149: ISO 5832-1:2007, Implants for surgery -- Metallic materials -- Part 1: Wrought stainless steel. (Materials)

Date of Standard: 2007.

Address of Standards 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:

International, Horizontal

Extent of Recognition:

This standard includes requirements for chemical composition, metallurgical characteristics, and mechanical properties in various conditions. Although this material has a long history of successful use for implants, the standard has no specific requirements regarding biologic response. Refer to the appropriate biocompatibility standards for specific biocompatibility requirements. Additional information must be provided to document that the design of the product will provide adequate mechanical properties for the particular application. Depending on the device application, additional material property data (such as fatigue life, wear and abrasion resistance, pitting or crevice corrosion resistance, and magnetic susceptibility) may be required beyond what is addressed by this standard.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§872.3130	Anchor, Preformed	Class 1	EJX

Regulation Number	Device Name	Device Class	Product Code
§872.3165	Attachment, Precision, All	Class 1	EGG

Regulation Number	Device Name	Device Class	Product Code
§872.3240	Bur, Dental	Class 1	EJL

Regulation Number	Device Name	Device Class	Product Code
§872.3285	Clasp, Preformed	Class 1	EHP

Regulation Number	Device Name	Device Class	Product Code
§872.3330	Crown, Preformed	Class 1	ELZ

Regulation Number	Device Name	Device Class	Product Code
§872.3350	Cusp, Gold And Stainless Steel	Class 1	ELO

Regulation Number	Device Name	Device Class	Product Code
§872.3360	Cusp, Preformed	Class 1	EHQ

Regulation Number	Device Name	Device Class	Product Code
§872.3580	Teeth, Preformed Gold Denture	Class 1	ELN

Regulation Number	Device Name	Device Class	Product Code
§872.3740	Pin, Retentive And Splinting, And Accessory Instruments	Class 1	EBL

Regulation Number	Device Name	Device Class	Product Code
§872.3810	Post, Root Canal	Class 1	ELR

Regulation Number	Device Name	Device Class	Product Code
§872.3900	Teeth, Artificial, Posterior With Metal Insert	Class 1	ELJ

Regulation Number	Device Name	Device Class	Product Code
§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

Regulation Number	Device Name	Device Class	Product Code
§872.4130	Drill, Dental, Intraoral	Class 1	DZA

Regulation Number	Device Name	Device Class	Product Code
§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

Regulation Number	Device Name	Device Class	Product Code
§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

Regulation Number	Device Name	Device Class	Product Code
§872.4600	Lock, Wire, And Ligature, Intraoral	Class 2	DYX

Regulation Number	Device Name	Device Class	Product Code
§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

Regulation Number	Device Name	Device Class	Product Code
§872.4880	Screw, Fixation, Intraosseous	Class 2	DZL

Regulation Number	Device Name	Device Class	Product Code
§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

Regulation Number	Device Name	Device Class	Product Code
§872.5500	Headgear, Extraoral, Orthodontic	Class 2	DZB

No Product Code information listed for §888.3XXX, Metallic components of all implantables