FDA Device Explorer

Dental (DE) FDA Submissions

Browse FDA 510(k), De Novo, and PMA medical device clearances for the Dental (DE) review panel, including product codes, regulations, and cleared devices.

CFR Parts: Part 872

Subparts

Product Codes

Product CodeDevice NameRegulationClassDevices
JEOMeasurer, Gingival Fluid872.150010
EATTester, Pulp872.1720222
EASGel, Electrode, For Pulp Tester872.173010
LFCDevice, Caries Detection872.1740217
NYHPlaque Disclosing Kit872.174021
NBLLaser, Fluorescence Caries Detection872.1745223
NTKCaries Detector, Laser Light, Transmission872.1745211
SBCDental Image Analyzer872.177021
EHDUnit, X-Ray, Extraoral With Timer872.18002189
MUHSystem, X-Ray, Extraoral Source, Digital872.18002206
EAPUnit, X-Ray, Intraoral872.1810242
EHAAligner, Beam, X-Ray872.182011
EAGCephalometer872.1830210
EHBCollimator, X-Ray872.184015
EAHCone, Radiographic, Lead-Lined872.185012
MVHDevice, Detection, Sulfide872.187021
EGZHolder, Film, X-Ray872.190518
NFPDevice, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders872.205020
NFQDevice, Dental Sonography, For Monitoring Jaw Sounds872.205014
NFRDevice, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders872.206020
NFSDevice, Jaw Tracking, For Monitoring Jaw Positions872.206012
EITApplicator, Rapid Wax, Dental872.306021
EJSAlloy, Other Noble Metal872.30602194
EJTAlloy, Gold-Based Noble Metal872.30602627
EJJAlloy, Amalgam872.3070274
ELYMercury872.307024
OIVDental Amalgam872.307023
EHEDispenser, Mercury And/Or Alloy872.308012
EFDAmalgamator, Dental, Ac-Powered872.3100115
DZSCapsule, Dental, Amalgam872.311014
EJXAnchor, Preformed872.313011
KXRApplicator, Resin872.314013
EJPArticulators872.3150111
KZOInk, Arch Tracing872.315012
EGGAttachment, Precision, All872.3165124
EHOBar, Preformed872.316513
KLEAgent, Tooth Bonding, Resin872.32002418
KCRFacebow872.322011
EJLBur, Dental872.3240127
NMEBur, Diamond Coated, Reprocessed872.324010
EJKLiner, Cavity, Calcium Hydroxide872.3250277
LBHVarnish, Cavity872.32602135
PHRDiammine Silver Fluoride Dental Hypersensitivity Varnish872.326028
PMEExternal Cleaning Solution872.326023
EMACement, Dental872.32752504
EMBZinc Oxide Eugenol872.3275111
MZWDental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief872.327522
NEACement, Ear, Nose And Throat872.327526
EHPClasp, Preformed872.328518
EJWClasp, Wire872.328513
EBECoating, Denture Hydrophilic, Resin872.330023
EBDCoating, Filling Material, Resin872.3310252
ELZCrown, Preformed872.333019
ELOCusp, Gold And Stainless Steel872.335010
EHQCusp, Preformed872.336010
KOMAdhesive, Denture, Acacia And Karaya With Sodium Borate872.340011
KORAdhesive, Denture, Karaya With Sodium Borate872.340030
MMUAdhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight872.340030
KOLAdhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer872.341012
KOQAdhesive, Denture, Carboxymethylcellulose Sodium (40-100&)872.341014
KXWAdhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer872.341010
KOSAdhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer872.342030
KOPAdhesive, Denture, Karaya872.345011
KXXAdhesive, Denture, Karaya And Ethylene-Oxide Homopolymer872.345011
KONAdhesive, Denture, Polyacrylamide Polymer (Modified Cationic)872.348030
KOOAdhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt872.349014
KOTCarboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium872.349018
KXYPolyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce872.350030
EFTCleanser, Denture, Over The Counter872.3520126
NUXCleanser, Denture, Prescription872.352010
JERCleaner, Denture, Mechanical872.3530114
EHRPad, Denture, Over The Counter872.354020
EHSCushion, Denture, Over The Counter872.354023
NKJCushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter872.354010
EBPReliner, Denture, Over The Counter872.356023
EBODenture Repair Kit872.357027
ELNTeeth, Preformed Gold Denture872.358011
ELMDenture, Plastic, Teeth872.3590255
PZYAdditively Manufactured, Preformed, Resin Denture Tooth872.359021
EKODenture Preformed (Partially Prefabricated Denture)872.360024
NHAAbutment, Implant, Dental, Endosseous872.36302702
PNPDental Abutment Design Software For Dental Laboratory872.363028
DZEImplant, Endosseous, Root-Form872.364021543
NRQBlade-Form Endosseous Dental Implant872.364025
OATImplant, Endosseous, Orthodontic872.3640251
ELEImplant, Subperiosteal872.364524
ELWMaterial, Impression872.36602402
SHIImpression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter872.366022
KZNScanner, Color872.366122
NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations872.366125
QJKIntraoral Camera872.366120
EBHMaterial, Impression Tray, Resin872.3670130
NFEMaterials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation872.368020
EBFMaterial, Tooth Shade, Resin872.36902924
OFWRestorative Instrument And Component Tray872.369020
EJHAlloy, Metal, Base872.37102153
KCSPantograph872.373010
EBLPin, Retentive And Splinting, And Accessory Instruments872.3740111
DYHAdhesive, Bracket And Tooth Conditioner, Resin872.37502192
KZPSolution, Cement Dissolving872.375022
EBIResin, Denture, Relining, Repairing, Rebasing872.37602328
EBCSealant, Pit And Fissure, And Conditioner872.37652130
EBGCrown And Bridge, Temporary, Resin872.37702189
POWCrown And Bridge, Long-Term Temporary, Resin872.377021
ELRPost, Root Canal872.3810135
KIFResin, Root Canal Filling872.38202143
MMTResin, Root Canal Filling Containing Chloroform872.382030
NYDEndodontic Kit872.382020
EKNPoint, Paper, Endodontic872.383017
EKLPoint, Silver, Endodontic872.384013
EKMGutta-Percha872.3850123
ELSSplint, Endodontic Stabilizing872.389026
ELJTeeth, Artificial, Posterior With Metal Insert872.390010
ELKTeeth, Artificial, Backing And Facing872.391012
ELLTeeth, Porcelain872.3920239
LYCBone Grafting Material, Synthetic872.39302229
NPKBarrier, Synthetic, Intraoral872.3930231
NPLBarrier, Animal Source, Intraoral872.3930257
NPMBone Grafting Material, Animal Source872.3930239
NPZBone Grafting Material, Dental, With Biologic Component872.393033
NQABiologic Material, Dental872.393031
NUNBone Grafting Material, Human Source872.3930215
LZDJoint, Temporomandibular, Implant872.394033
MPIGlenoid Fossa Prosthesis872.395031
MPLMandibular Condyle Prosthesis872.396030
MPJInterarticular Disc Prosthesis (Interpositional Implant)872.397030
NDPAccessories, Implant, Dental, Endosseous872.398014
NYEFixture Mount Kit872.398010
OFYDental Implant Surgical Tray872.398010
QRQNon-Irrigation Endosseous Dental Implant Drill Bits872.398010
QUAIntraoral Cooling Device872.559022
SGQIntraoral Phototherapy Device872.559521
DZHSaw, Bone, Ac-Powered872.412024
DZIDrill, Bone, Powered872.4120248
DZJDriver, Wire, And Bone Drill, Manual872.4120231
KMWHandpiece, Rotary Bone Cutting872.412029
MXFSystem, Dental, Hydrokinetic, Caries Removal & Cavity Preparation872.412025
PLVDental Stereotaxic Instrument872.4120223
QRYDental Navigation System872.412024
DZADrill, Dental, Intraoral872.4130113
EBWController, Foot, Handpiece And Cord872.4200161
EFAHandpiece, Belt And/Or Gear Driven, Dental872.4200125
EFBHandpiece, Air-Powered, Dental872.42001261
EGSHandpiece, Contra- And Right-Angle Attachment, Dental872.4200173
EKXHandpiece, Direct Drive, Ac-Powered872.4200189
EKYHandpiece, Water-Powered872.420012
NYLHandpiece, Air-Powered, Root Canal Irrigation872.420015
EGQInjector, Jet, Gas-Powered872.446521
EGMInjector, Jet, Mechanical-Powered872.4475211
DZPInstrument, Diamond, Dental872.4535121
NLDInstrument, Diamond, Dental, Reprocessed872.453510
DZNInstruments, Dental Hand872.4565116
EAXMirror, Mouth872.4565112
ECBUnit, Syringe, Air And/Or Water872.4565112
ECPInstrument, Ligature Tucking, Orthodontic872.456510
ECQAligner, Bracket, Orthodontic872.456512
ECRSetter, Band, Orthodontic872.456513
ECSPusher, Band, Orthodontic872.456512
ECTDriver, Band, Orthodontic872.456510
EFKForceps, Articulation Paper872.456510
EFLForceps, Dressing, Dental872.456515
EGIParallelometer872.456511
EGNScissors, Surgical Tissue, Dental872.456517
EIBSyringe, Irrigating (Dental)872.456514
EICSyringe, Periodontic, Endodontic, Irrigating872.4565116
EIDSyringe, Restorative And Impression Material872.4565113
EIFAccessories, Retractor, Dental872.456514
EIGRetractor, All Types872.456518
EIKCarver, Wax, Dental872.456515
EILGauge, Depth, Instrument, Dental872.456518
EIRScissors, Collar And Crown872.456511
EISRemover, Crown872.4565119
EIXProbe, Periodontic872.456519
EIYInstrument, Filling, Plastic, Dental872.456515
EJBHandle, Instrument, Dental872.456518
EJYPliers, Operative872.456512
EJZKnife, Margin Finishing, Operative872.456512
EKAFile, Margin Finishing, Operative872.456512
EKBExplorer, Operative872.456513
EKCExcavator, Dental, Operative872.456512
EKDInstrument, Cutting, Operative872.456512
EKECurette, Operative872.456510
EKFInstrument, Contouring, Matrix, Operative872.456510
EKGCondenser, Amalgam And Foil, Operative872.456513
EKHCarver, Dental Amalgam, Operative872.456513
EKICarrier, Amalgam, Operative872.456512
EKJBurnisher, Operative872.4565172
EKKSpreader, Pulp Canal Filling Material, Endodontic872.456511
EKPReamer, Pulp Canal, Endodontic872.456516
EKQPreparer, Root Canal Endodontic872.456512
EKRPlugger, Root Canal, Endodontic872.456516
EKSFile, Pulp Canal, Endodontic872.4565131
EKTCurette, Endodontic872.456510
EKWBroach, Endodontic872.456517
ELAInstrument, Hand, Calculus Removal872.456514
EMDHemostat, Surgical872.456512
EMEPunch, Biopsy, Surgical872.456513
EMGForceps, Tooth Extractor, Surgical872.4565110
EMHForceps, Rongeur, Surgical872.456518
EMIFile, Bone, Surgical872.456514
EMJElevator, Surgical, Dental872.456516
EMKCurette, Surgical, Dental872.456511
EMLChisel, Bone, Surgical872.456512
EMMChisel, Osteotome, Surgical872.456514
EMNScaler, Periodontic872.456515
EMOKnife, Periodontic872.456510
EMPMarker, Periodontic872.456510
EMQHoe, Periodontic872.456510
EMRFile, Periodontic872.456511
EMSCurette, Periodontic872.456517
JEPRetainer, Matrix872.456513
JEXPlier, Orthodontic872.456517
NYCDental Prophylaxis Kit872.456510
NYFGingival Retraction Kit872.456510
NYGLapping Tool Kit872.456510
PWLOral Surgery Tray872.456510
DYXLock, Wire, And Ligature, Intraoral872.4600211
EAYLight, Fiber Optic, Dental872.4620118
EAZLight, Operating, Dental872.4630123
EBALight, Surgical Headlight872.4630110
DZMNeedle, Dental872.4730116
NMWNeedle, Dental, Reprocessed872.473010
JEYPlate, Bone872.47602292
MDLImplant, Transmandibular872.476022
MQNExternal Mandibular Fixator And/Or Distractor872.4760260
NEIProsthesis, Condyle, Mandibular, Temporary872.477027
ELBScaler, Rotary872.484026
ELCScaler, Ultrasonic872.48502195
DZKWire, Fixation, Intraosseous872.488022
DZLScrew, Fixation, Intraosseous872.4880280
EKZUnit, Electrosurgical, And Accessories, Dental872.4920219
DYJRetainer, Screw Expansion, Orthodontic872.541015
DYOBand, Material, Orthodontic872.541013
DZCWire, Orthodontic872.5410130
DZDTube, Orthodontic872.541018
ECIBand, Elastic, Orthodontic872.5410125
ECMBand, Preformed, Orthodontic872.541012
ECNClamp, Wire, Orthodontic872.541010
ECOSpring, Orthodontic872.541017
EJFBracket, Metal, Orthodontic872.54101103
NQSBracket, Metal, Orthodontic, Reprocessed872.541010
QJJIndirect Bonding Tray872.541010
DYWBracket, Plastic, Orthodontic872.5470242
NJMBracket, Ceramic, Orthodontic872.5470260
NLCBracket, Plastic, Orthodontic, Reprocessed872.547020
NXCAligner, Sequential872.54702143
OYHOrthodontic Vibratory Accessory872.547025
PLHOrthodontic Led Accessory872.547022
PNNOrthodontic Software872.5470233
DZBHeadgear, Extraoral, Orthodontic872.5500236
DYTMaintainer, Space Preformed, Orthodontic872.552514
KMYPositioner, Tooth, Preformed872.5525112
KKORing, Teething, Fluid-Filled872.5550227
MEFRing, Teething, Non-Fluid Filled872.555011
LTFStimulator, Salivary System872.556023
QTTOver The Counter Electrical Salivary Stimulatory System872.556022
LQZDevice, Jaw Repositioning872.5570227
LRKDevice, Anti-Snoring872.55702210
MYBPillow, Cervical (For Mild Sleep Apnea)872.557026
OHPExpiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea872.557025
ORYTongue Suspension System872.5570210
OZRIntraoral Pressure Gradient Device872.557026
PLCSleep Appliances With Patient Monitoring872.557029
QCJClosed Loop Auto Titration Device For Oral Appliances872.557121
QNONeuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea872.557523
NTORinse, Oral, Antibacterial (By Physical Means)872.558022
EEJGuard, Disk872.601011
EHJDisk, Abrasive872.601014
EHLPoint, Abrasive872.601014
EHMStrip, Polishing Agent872.601012
EJQWheel, Polishing Agent872.601011
EJRAgent, Polishing, Abrasive, Oral Cavity872.6030177
EFNCotton, Roll872.6050114
KHRAbsorber, Saliva, Paper872.6050110
EBZActivator, Ultraviolet, For Polymerization872.60702213
QNFLaser Activator For Polymerization872.607022
KOJAirbrush872.6080248
PIPProphy Powder, Airbrush Accessory872.608022
EFCWarmer, Anesthetic Tube872.610010
QGOComposite Resin Warmer872.610011
EFHPaper, Articulation872.6140110
EEAPlate, Base, Shellac872.620010
KLCChair, Dental, With Operative Unit872.6250163
NRUChair, Dental, Without Operative Unit872.625010
EHKCup, Prophylaxis872.629018
EEFClamp, Rubber Dam872.630013
EIEDam, Rubber872.6300133
EJEFrame, Rubber Dam872.630013
EJGForceps, Rubber Dam Clamp872.630011
EAQDetector, Ultraviolet872.635022
NXVDiagnostic Light, Soft Tissue Detector872.6350212
JESFloss, Dental872.6390162
EEGHeat Source For Bleaching Teeth872.6475112
EFSUnit, Oral Irrigation872.6510147
OGTOral Irrigation Kit872.651010
KCQTube Impression And Matrix872.657011
DYNMouthpiece, Saliva Ejector872.6640118
EBRUnit, Suction Operatory872.664013
EHZEvacuator, Oral Cavity872.6640117
EIAUnit, Operative Dental872.66401284
NRDUnit, Operative Dental, Accessories872.664012
OFXGeneral Purpose Dental Tray872.664010
QYJDental Waterline Treatment Cartridge872.664011
JETPick, Massaging872.6650115
JEWTip, Rubber, Oral Hygiene872.665013
EIHPowder, Porcelain872.66602480
EFXProtector, Silicate872.667010
ECGSterilizer, Boiling Water872.671017
ECCSterilizer, Glass Bead872.673030
KOKSterilizer, Endodontic Dry Heat872.673030
EJISyringe, Cartridge872.6770245
EFWToothbrush, Manual872.6855149
LCNScraper, Tongue872.6855131
MAUEraser, Dental Stain872.685512
MCFUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile872.685515
NOBUnit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile872.685510
NSBPatient Personal Hygiene Kit872.685510
NXZDental Hygiene Kit872.685510
QJCPlaque Disclosing Agent872.685511
JEQToothbrush, Powered872.6865154
MMDToothbrush, Ionic, Battery-Powered872.686512
QIAPowered Tongue Scraper872.686511
QMJPowered Radiofrequency Toothbrush872.686622
KMTTray, Fluoride, Disposable872.687018
EHYTray, Impression, Preformed872.6880116
EGDWax, Dental, Intraoral872.6890125
PFLIntraoral, Dental Foam Protector872.689011
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