ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
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DENTAL DEVICES

 

All devices in this list are 510(k) exempt unless further qualified

508
DENTAL MEDICAL DEVICES: PREMARKET NOTIFICATION 510(k) EXEMPT

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.

EXEMPTED DENTAL DEVICES LIST

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

EXEMPTION LIMITATIONS

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).

FDA ESTABLISHMENT REGISTRATION

However, U.S. initial importers as well as all manufacturers of 510(k) exempt dental medical devices are required to register their establishment and list the generic category or classification name.

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