| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
053
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Date of Entry 12/23/2019
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|
FR Recognition Number
|
4-261
|
| Standard | |
ISO 7405 Third edition 2018-10 Corrected version 2018-12
Dentistry - Evaluation of biocompatibility of medical devices used in dentistry |
|
Scope/AbstractThis document 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 document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.
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|
| Extent of Recognition
|
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 |
| §872.1720 |
Tester, Pulp
|
Class 2
|
EAT
|
| §872.1740 |
Device, Caries Detection
|
Class 2
|
LFC
|
| §872.3060 |
Applicator, Rapid Wax, Dental
|
Class 2
|
EIT
|
| §872.3060 |
Alloy, Other Noble Metal
|
Class 2
|
EJS
|
| §872.3060 |
Alloy, Gold-Based Noble Metal
|
Class 2
|
EJT
|
| §872.3070 |
Alloy, Amalgam
|
Class 2
|
EJJ
|
| §872.3070 |
Mercury
|
Class 2
|
ELY
|
| §872.3150 |
Ink, Arch Tracing
|
Class 1
|
KZO
|
| §872.3200 |
Agent, Tooth Bonding, Resin
|
Class 2
|
KLE
|
| §872.3250 |
Liner, Cavity, Calcium Hydroxide
|
Class 2
|
EJK
|
| §872.3260 |
Varnish, Cavity
|
Class 2
|
LBH
|
| §872.3275 |
Cement, Dental
|
Class 2
|
EMA
|
| §872.3300 |
Coating, Denture Hydrophilic, Resin
|
Class 2
|
EBE
|
| §872.3310 |
Coating, Filling Material, Resin
|
Class 2
|
EBD
|
| §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
|
| §872.3420 |
Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer
|
Class 3
|
KOS
|
| §872.3480 |
Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)
|
Class 3
|
KON
|
| §872.3500 |
Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce
|
Class 3
|
KXY
|
| §872.3540 |
OTC denture cushion or pad.
|
|
|
| §872.3560 |
Reliner, Denture, Over The Counter
|
Class 2
|
EBP
|
| §872.3570 |
Denture Repair Kit
|
Class 2
|
EBO
|
| §872.3590 |
Denture, Plastic, Teeth
|
Class 2
|
ELM
|
| §872.3600 |
Denture Preformed (Partially Prefabricated Denture)
|
Class 2
|
EKO
|
| §872.3640 |
Implant, Endosseous, Root-Form
|
Class 2
|
DZE
|
| §872.3645 |
Implant, Subperiosteal
|
Class 2
|
ELE
|
| §872.3660 |
Material, Impression
|
Class 2
|
ELW
|
| §872.3690 |
Material, Tooth Shade, Resin
|
Class 2
|
EBF
|
| §872.3710 |
Alloy, Metal, Base
|
Class 2
|
EJH
|
| §872.3750 |
Adhesive, Bracket And Tooth Conditioner, Resin
|
Class 2
|
DYH
|
| §872.3750 |
Solution, Cement Dissolving
|
Class 2
|
KZP
|
| §872.3760 |
Resin, Denture, Relining, Repairing, Rebasing
|
Class 2
|
EBI
|
| §872.3765 |
Sealant, Pit And Fissure, And Conditioner
|
Class 2
|
EBC
|
| §872.3770 |
Crown And Bridge, Temporary, Resin
|
Class 2
|
EBG
|
| §872.3820 |
Resin, Root Canal Filling
|
Class 2
|
KIF
|
| §872.3820 |
Resin, Root Canal Filling Containing Chloroform
|
Class 3
|
MMT
|
| §872.3890 |
Splint, Endodontic Stabilizing
|
Class 2
|
ELS
|
| §872.3920 |
Teeth, Porcelain
|
Class 2
|
ELL
|
| §872.3930 |
Bone Grafting Material, For Dental Bone Repair
|
Class 2
|
LPK
|
| §872.3940 |
Joint, Temporomandibular, Implant
|
Class 3
|
LZD
|
| §872.3950 |
Glenoid Fossa Prosthesis
|
Class 3
|
MPI
|
| §872.3960 |
Mandibular Condyle Prosthesis
|
Class 3
|
MPL
|
| §872.3970 |
Interarticular Disc Prosthesis (Interpositional Implant)
|
Class 3
|
MPJ
|
| §872.4120 |
Saw, Bone, Ac-Powered
|
Class 2
|
DZH
|
| §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
|
| §872.4200 |
Handpiece, Belt And/Or Gear Driven, Dental
|
Class 1
|
EFA
|
| §872.4200 |
Handpiece, Air-Powered, Dental
|
Class 1
|
EFB
|
| §872.4200 |
Handpiece, Contra- And Right-Angle Attachment, Dental
|
Class 1
|
EGS
|
| §872.4465 |
Injector, Jet, Gas-Powered
|
Class 2
|
EGQ
|
| §872.4475 |
Injector, Jet, Mechanical-Powered
|
Class 2
|
EGM
|
| §872.4565 |
Parallelometer
|
Class 1
|
EGI
|
| §872.4600 |
Lock, Wire, And Ligature, Intraoral
|
Class 2
|
DYX
|
| §872.4760 |
Plate, Bone
|
Class 2
|
JEY
|
| §872.4760 |
Implant, Transmandibular
|
Class 2
|
MDL
|
| §872.4760 |
External Mandibular Fixator And/Or Distractor
|
Class 2
|
MQN
|
| §872.4840 |
Scaler, Rotary
|
Class 2
|
ELB
|
| §872.4850 |
Scaler, Ultrasonic
|
Class 2
|
ELC
|
| §872.4880 |
Screw, Fixation, Intraosseous
|
Class 2
|
DZL
|
| §872.4920 |
Unit, Electrosurgical, And Accessories, Dental
|
Class 2
|
EKZ
|
| §872.5470 |
Bracket, Plastic, Orthodontic
|
Class 2
|
DYW
|
| §872.5550 |
Ring, Teething, Fluid-Filled
|
Class 2
|
KKO
|
| §872.5570 |
Device, Jaw Repositioning
|
Class 2
|
LQZ
|
| §872.5570 |
Device, Anti-Snoring
|
Class 2
|
LRK
|
| §872.6080 |
Airbrush
|
Class 2
|
KOJ
|
| §872.6300 |
Clamp, Rubber Dam
|
Class 1
|
EEF
|
| §872.6300 |
Dam, Rubber
|
Class 1
|
EIE
|
| §872.6300 |
Frame, Rubber Dam
|
Class 1
|
EJE
|
| §872.6300 |
Forceps, Rubber Dam Clamp
|
Class 1
|
EJG
|
| §872.6640 |
Unit, Operative Dental
|
Class 1
|
EIA
|
| §872.6650 |
Tip, Rubber, Oral Hygiene
|
Class 1
|
JEW
|
| §872.6660 |
Powder, Porcelain
|
Class 2
|
EIH
|
| §872.6770 |
Syringe, Cartridge
|
Class 2
|
EJI
|
| §872.6855 |
Scraper, Tongue
|
Class 1
|
LCN
|
| §872.6855 |
Eraser, Dental Stain
|
Class 1
|
MAU
|
| §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
|
| N/A |
Saliva, Artificial |
|
LFD
|
| N/A |
Locator, Root Apex |
|
LQY
|
| N/A |
Device, Electrical Dental Anesthesia |
|
LWM
|
|
Relevant FDA Guidance and/or Supportive Publications*
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff, issued June 2016.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
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