• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Device Exemptions 510(k) and GMP Requirements

  • Print
  • Share
  • E-mail
-

Introduction

Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this list are 510(k) exempt unless further qualified by a footnote. Only devices annotated by (*) are also exempt from GMP except for general recordkeeping requirements and compliant files.

Class I Devices

FDA has exempted almost all class I devices (with the exception of Reserved Devices from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. Some 510(k) exemptions annotated with "\#\" are with certain limitations as noted in the footnotes. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892.

If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment and list the generic category or classification name. Registration and listing information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM) at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm

IMPORTANT NOTE: Only the class I devices with an asterisk (*) are also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.

Class II Devices

The Food and Drug Administration (FDA) has also published a list of class II (special controls) devices (those devices are annotated as "(II)"), subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act. Class II devices are annotated "(II)". Please note that class II devices are NOT exempt from GMP requirements.


PART 872 - DENTAL DEVICES Show All Parts
872.1500 gingival fluid measurer.  
872.1730 electrode gel for pulp testers.  
872.1820 dental x-ray exposure alignment device.  
872.1840 dental x-ray position indicating device.  
872.1850 lead-lined position indicator.  
872.1905 dental x-ray film holder.  *
872.2050 dental sonography device.  
872.2060 jaw tracking device.  
872.3060 noble metal alloy. (II)  
872.3080 mercury and alloy dispenser.  
872.3100 dental amalgamator.  
872.3110 dental amalgam capsule.  
872.3130 preformed anchor.  
872.3140 resin applicator.  *
872.3150 articulator.  *
872.3165 precision attachment.  
872.3220 facebow.  *
872.3240 dental bur. 90  
872.3275 dental cement.  
872.3285 preformed clasp.  
872.3330 preformed crown.  
872.3350 gold or stainless steel cusp.  
872.3360 preformed cusp.  
872.3400 karaya and sodium borate with or without acacia denture adhesive.  
872.3410 ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.  
872.3450 ethylene oxide homopolymer and/or karaya denture adhesive.  
872.3490 carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.  
872.3520 otc denture cleanser. 91  
872.3530 mechanical denture cleaner.  
872.3540 otc denture cushion or pad.  
872.3580 preformed gold denture tooth.  
872.3661 optical impression systems for cad/cam. (II) 88  
872.3670 resin impression tray material.  *
872.3710 base metal alloy. (II)  
872.3730 pantograph.  *
872.3740 retentive and splinting pin.  
872.3810 root canal post.  
872.3830 endodontic paper point.  
872.3840 endodontic silver point.  
872.3850 gutta percha.  
872.3900 posterior artificial tooth with a metal insert.  
872.3910 backing and facing for an artificial tooth.  
872.3980 endosseous dental implant accessories.  
872.4130 intraoral dental drill.  
872.4535 dental diamond instrument. 92  
872.4565 dental hand instrument. 93  
872.4620 fiber optic dental light.  
872.4630 dental operating light.  
872.4730 dental injecting needle. 94  
872.5410 orthodontic appliance and accessories. 95  
872.5525 preformed tooth positioner.  
872.5550 teething ring. 17  
872.6010 abrasive device and accessories.  *
872.6030 oral cavity abrasive polishing agent.  
872.6050 saliva absorber.  *
872.6100 anesthetic warmer.  
872.6140 articulation paper.  *
872.6200 base plate shellac.  *
872.6250 dental chair and accessories. 18  
872.6290 prophylaxis cup.  *
872.6300 rubber dam and accessories. 19  *
872.6390 dental floss. 20  
872.6475 heat source for bleaching teeth.  
872.6510 oral irrigation unit.  
872.6570 impression tube.  *
872.6640 dental operative unit and accessories. 21  
872.6650 massaging pick or tip for oral hygiene.  *
872.6670 silicate protector.  *
872.6855 manual toothbrush.  
872.6855 manual toothbrush.  *
872.6865 powered toothbrush.  
872.6870 disposable fluoride tray.  *
872.6880 preformed impression tray.  *
872.6890 intraoral dental wax.  
872.6890 intraoral dental wax.  *




Footnotes:

5 Exemption is limited to air-conduction hearing aids.
17 510(k) exempt if the teething ring does not contain a fluid.
18 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).
19 Only accessories are 510(k) exempt.
20 510(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.
21 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).
88 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; Guidance for Industry and FDA.''
90 Reprocessed diamond-coated bur, product code NME, requires 510(k) clearance.
91 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.
92 Reprocessed diamond dental instrument, product code NLD, requires 510(k) clearance. Diamond dental instrument, product code DZP, is 510(k) exempt.
93 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 of this chapter subject to the limitations in §872.9.
The following three product codes associated with this regulation require 510(k) clearance. There are 59 product codes associated with this regulation that are exempt from 510(k).
Dental lapping tool kit, product code NYG, requires 510(k) clearance. Parallelometer, product code EGI, requires 510(k) clearance. (Dental) irrigating syringe, product code EIB, requires 510(k) clearance.
94 Reprocessed dental needle, product code NMW, requires 510(k) clearance. Dental needle, product code DZM, is exempt from 510(k).
95 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).
-
-