|
|
| Section No. |
Regulation Name
Product Code-Device Name |
Class |
|
| 872.1740 |
Caries detection device. |
II
|
|
| |
LFC - Device, Caries Detection |
|
|
| 872.1745 |
Laser fluorescence caries detection device. |
II
|
|
| |
NTK - Caries Detector, Laser Light, Transmission |
|
|
| 872.1800 |
Extraoral source x-ray system. |
II
|
|
| |
EHD - Unit, X-Ray, Extraoral With Timer |
|
|
| |
MUH - System, X-Ray, Extraoral Source, Digital |
|
|
| 872.1810 |
Intraoral source x-ray system. |
II
|
|
| |
EAP - Unit, X-Ray, Intraoral |
|
|
| 872.1830 |
Cephalometer. |
II
|
|
| |
EAG - Cephalometer |
|
|
| 872.1870 |
Sulfide detection device. |
II
|
|
| |
MVH - Device, Detection, Sulfide |
|
|
| 872.3070 |
Dental amalgam, mercury, and amalgam alloy. |
II
|
|
| |
EJJ - Alloy, Amalgam |
|
|
| |
ELY - Mercury |
|
|
| |
OIV - Dental Amalgam |
|
|
| 872.3200 |
Resin tooth bonding agent. |
II
|
|
| |
KLE - Agent, Tooth Bonding, Resin |
|
|
| 872.3240 |
Dental bur. |
I
|
|
| |
NME - Bur, Diamond Coated, Reprocessed |
|
|
| 872.3250 |
Calcium hydroxide cavity liner. |
II
|
|
| |
EJK - Liner, Cavity, Calcium Hydroxide |
|
|
| 872.3260 |
Cavity varnish. |
II
|
|
| |
LBH - Varnish, Cavity |
|
|
| |
PHR - Diammine Silver Fluoride Dental Hypersensitivity Varnish |
|
|
| 872.3275 |
Dental cement. |
II
|
|
| |
EMA - Cement, Dental |
|
|
| |
MZW - Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief |
|
|
| 872.3310 |
Coating material for resin fillings. |
II
|
|
| |
EBD - Coating, Filling Material, Resin |
|
|
| 872.3660 |
Impression material. |
II
|
|
| |
ELW - Material, Impression |
|
|
| 872.3690 |
Tooth shade resin material. |
II
|
|
| |
EBF - Material, Tooth Shade, Resin |
|
|
| 872.3750 |
Bracket adhesive resin and tooth conditioner. |
II
|
|
| |
DYH - Adhesive, Bracket And Tooth Conditioner, Resin |
|
|
| |
KZP - Solution, Cement Dissolving |
|
|
| 872.3760 |
Denture relining, repairing, or rebasing resin. |
II
|
|
| |
EBI - Resin, Denture, Relining, Repairing, Rebasing |
|
|
| 872.3765 |
Pit and fissure sealant and conditioner. |
II
|
|
| |
EBC - Sealant, Pit And Fissure, And Conditioner |
|
|
| 872.3770 |
Temporary crown and bridge resin. |
II
|
|
| |
EBG - Crown And Bridge, Temporary, Resin |
|
|
| |
POW - Crown And Bridge, Long-Term Temporary, Resin |
|
|
| 872.3820 |
Root canal filling resin. |
II
|
|
| |
KIF - Resin, Root Canal Filling |
|
|
| 872.3920 |
Porcelain tooth. |
II
|
|
| |
ELL - Teeth, Porcelain |
|
|
| 872.4120 |
Bone cutting instrument and accessories. |
II
|
|
| |
DZH - Saw, Bone, Ac-Powered |
|
|
| |
DZI - Drill, Bone, Powered |
|
|
| |
DZJ - Driver, Wire, And Bone Drill, Manual |
|
|
| |
KMW - Handpiece, Rotary Bone Cutting |
|
|
| |
MXF - System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation |
|
|
| 872.4200 |
Dental handpiece and accessories. |
I
|
|
| |
EBW - Controller, Foot, Handpiece And Cord |
|
|
| |
EFA - Handpiece, Belt And/Or Gear Driven, Dental |
|
|
| |
EFB - Handpiece, Air-Powered, Dental |
|
|
| |
EGS - Handpiece, Contra- And Right-Angle Attachment, Dental |
|
|
| |
EKX - Handpiece, Direct Drive, Ac-Powered |
|
|
| |
EKY - Handpiece, Water-Powered |
|
|
| |
NYL - Handpiece, Air-Powered, Root Canal Irrigation |
|
|
| 872.4465 |
Gas-powered jet injector. |
II
|
|
| |
EGQ - Injector, Jet, Gas-Powered |
|
|
| 872.4475 |
Spring-powered jet injector. |
II
|
|
| |
EGM - Injector, Jet, Mechanical-Powered |
|
|
| 872.4535 |
Dental diamond instrument. |
I
|
|
| |
NLD - Instrument, Diamond, Dental, Reprocessed |
|
|
| 872.4730 |
Dental injecting needle. |
I
|
|
| |
NMW - Needle, Dental, Reprocessed |
|
|
| 872.4840 |
Rotary scaler. |
II
|
|
| |
ELB - Scaler, Rotary |
|
|
| 872.4850 |
Ultrasonic scaler. |
II
|
|
| |
ELC - Scaler, Ultrasonic |
|
|
| 872.4920 |
Dental electrosurgical unit and accessories. |
II
|
|
| |
EKZ - Unit, Electrosurgical, And Accessories, Dental |
|
|
| 872.5410 |
Orthodontic appliance and accessories. |
I
|
|
| |
NQS - Bracket, Metal, Orthodontic, Reprocessed |
|
|
| 872.5470 |
Orthodontic plastic bracket. |
II
|
|
| |
DYW - Bracket, Plastic, Orthodontic |
|
|
| |
NJM - Bracket, Ceramic, Orthodontic |
|
|
| |
NLC - Bracket, Plastic, Orthodontic, Reprocessed |
|
|
| |
NXC - Aligner, Sequential |
|
|
| |
OYH - Orthodontic Vibratory Accessory |
|
|
| |
PLH - Orthodontic Led Accessory |
|
|
| |
PNN - Orthodontic Software |
|
|
| 872.5500 |
Extraoral orthodontic headgear. |
II
|
|
| |
DZB - Headgear, Extraoral, Orthodontic |
|
|
| 872.5570 |
Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. |
II
|
|
| |
OZR - Intraoral Pressure Gradient Device |
|
|
| |
LQZ - Device, Jaw Repositioning |
|
|
| |
LRK - Device, Anti-Snoring |
|
|
| |
OHP - Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea |
|
|
| |
PLC - Sleep Appliances With Patient Monitoring |
|
|
| |
MYB - Pillow, Cervical (For Mild Sleep Apnea) |
|
|
| 872.5580 |
Oral rinse to reduce the adhesion of dental plaque. |
II
|
|
| |
NTO - Rinse, Oral, Antibacterial (By Physical Means) |
|
|
| 872.6070 |
Ultraviolet activator for polymerization. |
II
|
|
| |
EBZ - Activator, Ultraviolet, For Polymerization |
|
|
| 872.6080 |
Airbrush. |
II
|
|
| |
KOJ - Airbrush |
|
|
| |
PIP - Prophy Powder, Airbrush Accessory |
|
|
| 872.6250 |
Dental chair and accessories. |
I
|
|
| |
KLC - Chair, Dental, With Operative Unit |
|
|
| 872.6350 |
Ultraviolet detector. |
II
|
|
| |
EAQ - Detector, Ultraviolet |
|
|
| |
NXV - Diagnostic Light, Soft Tissue Detector |
|
|
| 872.6640 |
Dental operative unit and accessories. |
I
|
|
| |
EIA - Unit, Operative Dental |
|
|
| 872.6660 |
Porcelain powder for clinical use. |
II
|
|
| |
EIH - Powder, Porcelain |
|
|
| 872.6710 |
Boiling water sterilizer. |
I
|
|
| |
ECG - Sterilizer, Boiling Water |
|
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