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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Recognition 07/09/2014 
FR Recognition Number 4-212
Standard
ISO 7405 Second edition 2008-12-15
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)]
Scope/Abstract
This International Standard specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test.

This International Standard does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

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
§872.6770 Syringe, Cartridge Class 2 EJI
§872.6660 Powder, Porcelain Class 2 EIH
§872.6640 Unit, Operative Dental Class 1 EIA
§872.6300 Clamp, Rubber Dam Class 1 EEF
§872.6300 Dam, Rubber Class 1 EIE
§872.6300 Forceps, Rubber Dam Clamp Class 1 EJG
§872.6300 Frame, Rubber Dam Class 1 EJE
§872.6080 Airbrush Class 2 KOJ
§872.5550 Ring, Teething, Fluid-Filled Class 2 KKO
§872.5470 Bracket, Plastic, Orthodontic Class 2 DYW
§872.4920 Unit, Electrosurgical, And Accessories, Dental Class 2 EKZ
§872.4880 Screw, Fixation, Intraosseous Class 2 DZL
§872.4850 Scaler, Ultrasonic Class 2 ELC
§872.4840 Scaler, Rotary Class 2 ELB
§872.4760 Plate, Bone Class 2 JEY
§872.4600 Lock, Wire, And Ligature, Intraoral Class 2 DYX
§872.4475 Injector, Jet, Mechanical-Powered Class 2 EGM
§872.4465 Injector, Jet, Gas-Powered Class 2 EGQ
§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
§872.4120 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
§872.3970 Interarticular Disc Prosthesis (Interpositional Implant) Class 3 MPJ
§872.3960 Mandibular Condyle Prosthesis Class 3 MPL
§872.3950 Glenoid Fossa Prosthesis Class 3 MPI
§872.3940 Joint, Temporomandibular, Implant Class 3 LZD
§872.3890 Splint, Endodontic Stabilizing Class 2 ELS
§872.3820 Resin, Root Canal Filling Class 2 KIF
§872.3820 Resin, Root Canal Filling Containing Chloroform Class 3 MMT
§872.3770 Crown And Bridge, Temporary, Resin Class 2 EBG
§872.3765 Sealant, Pit And Fissure, And Conditioner Class 2 EBC
§872.3760 Resin, Denture, Relining, Repairing, Rebasing Class 2 EBI
§872.3750 Adhesive, Bracket And Tooth Conditioner, Resin Class 2 DYH
§872.3710 Alloy, Metal, Base Class 2 EJH
§872.3070 Mercury Class 2 ELY
§872.3690 Material, Tooth Shade, Resin Class 2 EBF
§872.3660 Material, Impression Class 2 ELW
§872.3645 Implant, Subperiosteal Class 2 ELE
§872.3640 Implant, Endosseous, Root-Form Class 2 DZE
§872.3600 Denture Preformed (Partially Prefabricated Denture) Class 2 EKO
§872.3590 Denture, Plastic, Teeth Class 2 ELM
§872.3570 Denture Repair Kit Class 2 EBO
§872.3560 Reliner, Denture, Over The Counter Class 2 EBP
§872.3540 Pad, Denture, Over The Counter Class 2 EHR
§872.3540 Cushion, Denture, Over The Counter Class 2 EHS
§872.3540 Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter Class 1 NKJ
§872.3500 Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce Class 3 KXY
§872.3480 Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic) Class 3 KON
§872.3420 Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer Class 3 KOS
§872.3400 Adhesive, Denture, Acacia And Karaya With Sodium Borate Class 1 KOM
§872.3400 Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight Class 3 MMU
§872.3310 Coating, Filling Material, Resin Class 2 EBD
§872.3300 Coating, Denture Hydrophilic, Resin Class 2 EBE
§872.3275 Cement, Dental Class 2 EMA
§872.3260 Varnish, Cavity Class 2 LBH
§872.3250 Liner, Cavity, Calcium Hydroxide Class 2 EJK
§872.3200 Agent, Tooth Bonding, Resin Class 2 KLE
§872.3060 Alloy, Gold-Based Noble Metal Class 2 EJT
§872.3060 Alloy, Other Noble Metal Class 2 EJS
§872.3070 Alloy, Amalgam Class 2 EJJ
§872.1740 Device, Caries Detection Class 2 LFC
§872.1720 Tester, Pulp Class 2 EAT
Unclassified Device, Electrical Dental Anesthesia   LWM
Unclassified Laser, Dental   LYB
Unclassified Locator, Root Apex   LQY
Unclassified Saliva, Artificial   LFD
§872.3060 Applicator, Rapid Wax, Dental Class 2 EIT
§872.3150 Ink, Arch Tracing Class 1 KZO
§872.3750 Solution, Cement Dissolving Class 2 KZP
§872.3920 Teeth, Porcelain Class 2 ELL
§872.3930 Bone Grafting Material, For Dental Bone Repair Class 2 LPK
§872.4565 Parallelometer Class 1 EGI
§872.4760 External Mandibular Fixator And/Or Distractor Class 2 MQN
§872.4760 Implant, Transmandibular Class 2 MDL
§872.5570 Device, Anti-Snoring Class 2 LRK
§872.5570 Device, Jaw Repositioning Class 2 LQZ
§872.6650 Tip, Rubber, Oral Hygiene Class 1 JEW
§872.6855 Eraser, Dental Stain Class 1 MAU
§872.6855 Scraper, Tongue Class 1 LCN
§872.6865 Toothbrush, Ionic, Battery-Powered Class 1 MMD
§878.3500 Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction Class 2 KKY
§884.4520 Pelvimeter, External Class 1 HER
§890.3475 Device, Finger-Sucking Class 1 LQX
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Sherrill Macura
  FDA/OMPT/CDRH/ODE
  301-796-6375
  Sherrill.Macura@fda.hhs.gov
 Mehdi Kazemzadeh-Narbat
  FDA/OMPT/CDRH/ODE
  301-796-7451
  Mehdi.Kazemzadeh-Narbat@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Dental/ENT
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