Dental

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Code	Device name	Class	21 CFR	510(k) (3y)
KLE	Agent, Tooth Bonding, Resin	Class 2	21 CFR 872.3200	419
KMT	Tray, Fluoride, Disposable	Class 1	21 CFR 872.6870	8
KMW	Handpiece, Rotary Bone Cutting	Class 2	21 CFR 872.4120	9
KMY	Positioner, Tooth, Preformed	Class 1	21 CFR 872.5525	12
KOJ	Airbrush	Class 2	21 CFR 872.6080	48
KOK	Sterilizer, Endodontic Dry Heat	Class 3	21 CFR 872.6730
KOL	Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Ox	Class 1	21 CFR 872.3410	2
KOM	Adhesive, Denture, Acacia And Karaya With Sodium Borate	Class 1	21 CFR 872.3400	1
KON	Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic)	Class 3	21 CFR 872.3480
KOO	Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Do	Class 1	21 CFR 872.3490	4
KOP	Adhesive, Denture, Karaya	Class 1	21 CFR 872.3450	1
KOQ	Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)	Class 1	21 CFR 872.3410	4
KOR	Adhesive, Denture, Karaya With Sodium Borate	Class 3	21 CFR 872.3400
KOS	Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacry	Class 3	21 CFR 872.3420
KOT	Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Cal	Class 1	21 CFR 872.3490	8
KXR	Applicator, Resin	Class 1	21 CFR 872.3140	3
KXW	Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Ox	Class 1	21 CFR 872.3410
KXX	Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer	Class 1	21 CFR 872.3450	1
KXY	Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxyme	Class 3	21 CFR 872.3500
KZN	Scanner, Color	Class 2	21 CFR 872.3661	2
KZO	Ink, Arch Tracing	Class 1	21 CFR 872.3150	2
KZP	Solution, Cement Dissolving	Class 2	21 CFR 872.3750	2
LBH	Varnish, Cavity	Class 2	21 CFR 872.3260	138
LCN	Scraper, Tongue	Class 1	21 CFR 872.6855	31
LFC	Device, Caries Detection	Class 2	21 CFR 872.1740	17
LQZ	Device, Jaw Repositioning	Class 2	21 CFR 872.5570	27
LRK	Device, Anti-Snoring	Class 2	21 CFR 872.5570	215
LTF	Stimulator, Salivary System	Class 2	21 CFR 872.5560	2
LYC	Bone Grafting Material, Synthetic	Class 2	21 CFR 872.3930	231
LZD	Joint, Temporomandibular, Implant	Class 3	21 CFR 872.3940
MAU	Eraser, Dental Stain	Class 1	21 CFR 872.6855	2
MCF	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile	Class 1	21 CFR 872.6855	5
MDL	Implant, Transmandibular	Class 2	21 CFR 872.4760	2
MEF	Ring, Teething, Non-Fluid Filled	Class 1	21 CFR 872.5550	1
MMD	Toothbrush, Ionic, Battery-Powered	Class 1	21 CFR 872.6865	2
MMT	Resin, Root Canal Filling Containing Chloroform	Class 3	21 CFR 872.3820
MMU	Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weigh	Class 3	21 CFR 872.3400
MPI	Glenoid Fossa Prosthesis	Class 3	21 CFR 872.3950
MPJ	Interarticular Disc Prosthesis (Interpositional Implant)	Class 3	21 CFR 872.3970
MPL	Mandibular Condyle Prosthesis	Class 3	21 CFR 872.3960
MQN	External Mandibular Fixator And/Or Distractor	Class 2	21 CFR 872.4760	60
MUH	System, X-Ray, Extraoral Source, Digital	Class 2	21 CFR 872.1800	206
MVH	Device, Detection, Sulfide	Class 2	21 CFR 872.1870	1
MXF	System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation	Class 2	21 CFR 872.4120	5
MYB	Pillow, Cervical (For Mild Sleep Apnea)	Class 2	21 CFR 872.5570	6
MZW	Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain R	Class 2	21 CFR 872.3275	2
NBL	Light-Induced Fluorescence Caries Detector	Class 2	21 CFR 872.1745	24
NDP	Accessories, Implant, Dental, Endosseous	Class 1	21 CFR 872.3980	4
NEA	Cement, Ear, Nose And Throat	Class 2	21 CFR 872.3275	6
NEI	Prosthesis, Condyle, Mandibular, Temporary	Class 2	21 CFR 872.4770	7
NFE	Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial	Class 2	21 CFR 872.3680
NFP	Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders	Class 2	21 CFR 872.2050
NFQ	Device, Dental Sonography, For Monitoring Jaw Sounds	Class 1	21 CFR 872.2050	4
NFR	Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders	Class 2	21 CFR 872.2060
NFS	Device, Jaw Tracking, For Monitoring Jaw Positions	Class 1	21 CFR 872.2060	2
NHA	Abutment, Implant, Dental, Endosseous	Class 2	21 CFR 872.3630	713
NJM	Bracket, Ceramic, Orthodontic	Class 2	21 CFR 872.5470	60
NKJ	Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter	Class 1	21 CFR 872.3540
NLC	Bracket, Plastic, Orthodontic, Reprocessed	Class 2	21 CFR 872.5470
NLD	Instrument, Diamond, Dental, Reprocessed	Class 1	21 CFR 872.4535
NME	Bur, Diamond Coated, Reprocessed	Class 1	21 CFR 872.3240
NMW	Needle, Dental, Reprocessed	Class 1	21 CFR 872.4730
NOB	Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Ste	Class 1	21 CFR 872.6855
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing	Class 2	21 CFR 872.3661	5
NPK	Barrier, Synthetic, Intraoral	Class 2	21 CFR 872.3930	31
NPL	Barrier, Animal Source, Intraoral	Class 2	21 CFR 872.3930	57
NPM	Bone Grafting Material, Animal Source	Class 2	21 CFR 872.3930	40
NPZ	Bone Grafting Material, Dental, With Biologic Component	Class 3	21 CFR 872.3930
NQA	Biologic Material, Dental	Class 3	21 CFR 872.3930
NQS	Bracket, Metal, Orthodontic, Reprocessed	Class 1	21 CFR 872.5410
NRD	Unit, Operative Dental, Accessories	Class 1	21 CFR 872.6640	2
NRQ	Blade-Form Endosseous Dental Implant	Class 2	21 CFR 872.3640	5
NRU	Chair, Dental, Without Operative Unit	Class 1	21 CFR 872.6250
NSB	Patient Personal Hygiene Kit	Class 1	21 CFR 872.6855
NTK	Light Transmission Caries Detector	Class 2	21 CFR 872.1745	12
NTO	Rinse, Oral, Antibacterial (By Physical Means)	Class 2	21 CFR 872.5580	2
NUN	Bone Grafting Material, Human Source	Class 2	21 CFR 872.3930	15
NUX	Cleanser, Denture, Prescription	Class 1	21 CFR 872.3520
NXC	Aligner, Sequential	Class 2	21 CFR 872.5470	145
NXV	Diagnostic Light, Soft Tissue Detector	Class 2	21 CFR 872.6350	12
NXZ	Dental Hygiene Kit	Class 1	21 CFR 872.6855
NYC	Dental Prophylaxis Kit	Class 1	21 CFR 872.4565
NYD	Endodontic Kit	Class 2	21 CFR 872.3820
NYE	Fixture Mount Kit	Class 1	21 CFR 872.3980
NYF	Gingival Retraction Kit	Class 1	21 CFR 872.4565
NYG	Lapping Tool Kit	Class 1	21 CFR 872.4565
NYH	Plaque Disclosing Kit	Class 2	21 CFR 872.1740	1
NYL	Handpiece, Air-Powered, Root Canal Irrigation	Class 1	21 CFR 872.4200	5
OAT	Implant, Endosseous, Orthodontic	Class 2	21 CFR 872.3640	52
OFW	Restorative Instrument And Component Tray	Class 2	21 CFR 872.3690
OFX	General Purpose Dental Tray	Class 1	21 CFR 872.6640
OFY	Dental Implant Surgical Tray	Class 1	21 CFR 872.3980
OGT	Oral Irrigation Kit	Class 1	21 CFR 872.6510
OHP	Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea	Class 2	21 CFR 872.5570	5
OIV	Dental Amalgam	Class 2	21 CFR 872.3070	3
ORY	Tongue Suspension System	Class 2	21 CFR 872.5570	10
OYH	Orthodontic Vibratory Accessory	Class 2	21 CFR 872.5470	5
OZR	Intraoral Pressure Gradient Device	Class 2	21 CFR 872.5570	6
PFL	Intraoral, Dental Foam Protector	Class 1	21 CFR 872.6890	1
PHR	Diammine Silver Fluoride Dental Hypersensitivity Varnish	Class 2	21 CFR 872.3260	8
PIP	Prophy Powder, Airbrush Accessory	Class 2	21 CFR 872.6080	2
PLC	Sleep Appliances With Patient Monitoring	Class 2	21 CFR 872.5570	10
PLH	Orthodontic Led Accessory	Class 2	21 CFR 872.5470	2
PLV	Dental Stereotaxic Instrument	Class 2	21 CFR 872.4120	23
PME	External Cleaning Solution	Class 2	21 CFR 872.3260	3
PNN	Orthodontic Software	Class 2	21 CFR 872.5470	34
PNP	Dental Abutment Design Software For Dental Laboratory	Class 2	21 CFR 872.3630	8
POW	Crown And Bridge, Long-Term Temporary, Resin	Class 2	21 CFR 872.3770	2
PWL	Oral Surgery Tray	Class 1	21 CFR 872.4565
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Class 2	21 CFR 872.3590	1
QCJ	Closed Loop Auto Titration Device For Oral Appliances	Class 2	21 CFR 872.5571	1
QGO	Composite Resin Warmer	Class 1	21 CFR 872.6100	1
QIA	Powered Tongue Scraper	Class 1	21 CFR 872.6865	1
QJC	Plaque Disclosing Agent	Class 1	21 CFR 872.6855	1
QJJ	Indirect Bonding Tray	Class 1	21 CFR 872.5410
QJK	Intraoral Camera	Class 2	21 CFR 872.3661
QMJ	Powered Radiofrequency Toothbrush	Class 2	21 CFR 872.6866	2
QNF	Laser Activator For Polymerization	Class 2	21 CFR 872.6070	2
QNO	Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring An	Class 2	21 CFR 872.5575	3
QRQ	Non-Irrigation Endosseous Dental Implant Drill Bits	Class 1	21 CFR 872.3980
QRY	Dental Navigation System	Class 2	21 CFR 872.4120	5
QTT	Over The Counter Electrical Salivary Stimulatory System	Class 2	21 CFR 872.5560	2
QUA	Intraoral Cooling Device	Class 2	21 CFR 872.5590	2
QYJ	Dental Waterline Treatment Cartridge	Class 1	21 CFR 872.6640	1
SBC	Dental Image Analyzer	Class 2	21 CFR 872.1770	1
SGQ	Intraoral Phototherapy Device	Class 2	21 CFR 872.5595	1
SHI	Impression Material For Fabrication Of Patient-Matched Mouthguards, Ov	Class 2	21 CFR 872.3660	2
SHQ	Dental Image Analyzer, In-Office	Class 2	21 CFR 872.1770	1