Premarket Notification and Clearance are not required before marketing the following Class I medical devices in the United States.
Class II (special controls) devices (annotated as “(II)”), subject to certain limitations, are also exempt from premarket notification requirements.
Gingival Fluid Measurer
872.1500
Pulp Tester (II)
872.1720
Electrode Gel For Pulp Testers
872.1730
Dental X-Ray Exposure Alignment Device
872.1820
Dental X-Ray Position Indicating Device
872.1840
Lead-Lined Position Indicator
872.1850
Dental X-Ray Film Holder
872.1905
Dental Sonography Device
872.2050
Jaw Tracking Device
872.2060
Noble Metal Alloy (II)
872.3060
Mercury And Alloy Dispenser
872.3080
Dental Amalgamator
872.3100
Dental Amalgam Capsule
872.3110
Preformed Anchor
872.3130
Resin Applicator
872.3140
Articulator (II)
872.3150
Precision Attachment
872.3165
Facebow
872.3220
Dental Bur
872.3240
Cavity Varnish (II)
872.3260
Dental Cement
872.3275
Preformed Clasp
872.3285
Hydrophilic Resin Coating For Dentures (II)
872.3300
Preformed Crown
872.3330
Gold Or Stainless Steel Cusp
872.3350
Preformed Cusp
872.3360
Karaya And Sodium Borate With Or Without Acacia Denture Adhesive
872.3400
Ethylene Oxide Homopolymer And/Or Carboxymethylcellulose Sodium Denture Adhesive
872.3410
Ethylene Oxide Homopolymer And/Or Karaya Denture Adhesive
872.3450
Carboxymethylcellulose Sodium And/Or Polyvinylmethylether Maleic Acid Calcium-Sodium Double Salt Denture Adhesive
872.3490
Otc Denture Cleanser
872.3520
Mechanical Denture Cleaner
872.3530
Otc Denture Cushion Or Pad (II)
872.3540
Otc Denture Reliner (II)
872.3560
Preformed Gold Denture Tooth
872.3580
Preformed Plastic Denture Tooth (II)
872.3590
Partially Fabricated Denture Kit (II)
872.3600
Optical Impression Systems For Cad/Cam (II)
872.3661
Resin Impression Tray Material
872.3670
Base Metal Alloy (II)
872.3710
Pantograph
872.3730
Retentive And Splinting Pin
872.3740
Root Canal Post
872.3810
Endodontic Paper Point
872.3830
Endodontic Silver Point
872.3840
Gutta Percha
872.3850
Endodontic Stabilizing Splint (II)
872.3890
Posterior Artificial Tooth With A Metal Insert
872.3900
Backing And Facing For An Artificial Tooth
872.3910
Endosseous Dental Implant Accessories
872.3980
Intraoral Dental Drill
872.4130
Dental Diamond Instrument
872.4535
Dental Hand Instrument
872.4565
Fiber Optic Dental Light
872.4620
Dental Operating Light
872.4630
Dental Injecting Needle
872.4730
Orthodontic Appliance And Accessories
872.5410
Preformed Tooth Positioner
872.5525
Teething Ring (II)
872.5550
Teething Ring
872.5550
Abrasive Device And Accessories
872.6010
Oral Cavity Abrasive Polishing Agent
872.6030
Saliva Absorber
872.6050
Anesthetic Warmer
872.6100
Articulation Paper
872.6140
Base Plate Shellac
872.6200
Dental Chair And Accessories
872.6250
Prophylaxis Cup
872.6290
Rubber Dam And Accessories
872.6300
Dental Floss
872.6390
Heat Source For Bleaching Teeth
872.6475
Oral Irrigation Unit
872.6510
Impression Tube
872.6570
Dental Operative Unit And Accessories
872.6640
Massaging Pick Or Tip For Oral Hygiene
872.6650
Silicate Protector
872.6670
Cartridge Syringe (II)
872.6770
Manual Toothbrush
872.6855
Powered Toothbrush
872.6865
Disposable Fluoride Tray
872.6870
Preformed Impression Tray
872.6880
Intraoral Dental Wax
872.6890
Intraoral Dental Wax
872.6890
Dental Chair and Accessories
Only chairs without operative unit device are 510(k) exempt. Dental chair with operative unit, product code KLC, requires 510(k) clearance. Dental chair without operative unit, product code NRU, is exempt from 510(k).
Rubber Dam and Accessories
Only accessories are 510(k) exempt
Dental Floss
510(k) exempt only if the device is made of inert materials and is not coated or impregnated with chemicals intended to provide a therapeutic benefit or interact with tissues of the oral cavity.
Dental Operative Unit and Accessories
Only the accessories tray to the unit is 510(k) exempt. Dental operative unit, product code EIA, requires 510(k) clearance. Oral cavity evacuator, product code EHZ, is exempt from 510(k). Saliva ejector mouthpiece, product code DYN, is exempt from 510(k). Suction operatory unit, product code EBR, is exempt from 510(k). Operative dental unit accessories, product code NRD, is exempt from 510(k).
Optical Impression Systems for Cad/Cam (II)
If the device does not meet the following special control guidance, a 510(k) is required. “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations”.
Dental Bur
Reprocessed diamond-coated bur, product code NME, requires 510(k) clearance.
OTC Denture Cleanser
Prescription denture cleanser, product code NUX, requires 510(k) clearance. An Rx denture cleanser is an effervescent tablet for the removal of micro-organisms from removable dentures and retainers. Over the counter denture cleanser, product code EFT, is 510(k) exempt.
Dental Diamond Instrument
Reprocessed diamond dental instrument, product code NLD, requires 510(k) clearance. Diamond dental instrument, product code DZP, is 510(k) exempt.
Dental Hand Instrument
If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 subject to the limitations in §872.9. The following product code associated with this regulation requires 510(k) clearance: Dental lapping tool kit, product code NYG, requires 510(k) clearance.
Dental Injecting Needle
Reprocessed dental needle, product code NMW, requires 510(k) clearance. Dental needle, product code DZM, is exempt from 510(k).
Orthodontic Appliance and Accessories
Reprocessed orthodontic metal bracket, product code NQS, requires 510(k) clearance. Product codes ECI, DYO, ECM, EJF, ECN, DYJ, ECO, DZD, DZC, are exempt from 510(k).
However, U.S. initial importers as well as all manufacturers of Premarket Notification 510(k) exempt dental medical devices, are required to register their establishment and list the generic category or classification name.
