Home
gpo.gov
govinfo.gov

e-CFR Navigation Aids

Browse

Simple Search

Advanced Search

 — Boolean

 — Proximity

 

Search History

Search Tips

Corrections

Latest Updates

User Info

FAQs

Agency List

Incorporation By Reference

eCFR logo

Related Resources

Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We have made big changes to make the eCFR easier to use. Be sure to leave feedback using the Help button on the bottom right of each page!

e-CFR data is current as of September 29, 2020

Title 21Chapter ISubchapter HPart 872 → Subpart B


Title 21: Food and Drugs
PART 872—DENTAL DEVICES


Subpart B—Diagnostic Devices


Contents
§872.1500   Gingival fluid measurer.
§872.1720   Pulp tester.
§872.1730   Electrode gel for pulp testers.
§872.1740   Caries detection device.
§872.1745   Laser fluorescence caries detection device.
§872.1800   Extraoral source x-ray system.
§872.1810   Intraoral source x-ray system.
§872.1820   Dental x-ray exposure alignment device.
§872.1830   Cephalometer.
§872.1840   Dental x-ray position indicating device.
§872.1850   Lead-lined position indicator.
§872.1870   Sulfide detection device.
§872.1905   Dental x-ray film holder.
§872.2050   Dental sonography device.
§872.2060   Jaw tracking device.

return arrow Back to Top

§872.1500   Gingival fluid measurer.

(a) Identification. A gingival fluid measurer is a gauge device intended to measure the amount of fluid in the gingival sulcus (depression between the tooth and gums) to determine if there is a gingivitis condition.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38797, July 25, 2001]

return arrow Back to Top

§872.1720   Pulp tester.

(a) Identification. A pulp tester is an AC or battery powered device intended to evaluate the pulpal vitality of teeth by employing high frequency current transmitted by an electrode to stimulate the nerve tissue in the dental pulp.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]

return arrow Back to Top

§872.1730   Electrode gel for pulp testers.

(a) Identification. An electrode gel for pulp testers is a device intended to be applied to the surface of a tooth before use of a pulp tester to aid conduction of electrical current.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001]

return arrow Back to Top

§872.1740   Caries detection device.

(a) Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.

(b) Classification. Class II.

return arrow Back to Top

§872.1745   Laser fluorescence caries detection device.

(a) Identification. A laser fluorescence caries detection device is a laser, a fluorescence detector housed in a dental handpiece, and a control console that performs device calibration, as well as variable tone emitting and fluorescence measurement functions. The intended use of the device is to aid in the detection of tooth decay by measuring increased laser induced fluorescence.

(b) Classification. Class II, subject to the following special controls:

(1) Sale, distribution, and use of this device are restricted to prescription use in accordance with §801.109 of this chapter;

(2) Premarket notifications must include clinical studies, or other relevant information, that demonstrates that the device aids in the detection of tooth decay by measuring increased laser induced fluorescence; and

(3) The labeling must include detailed use instructions with precautions that urge users to:

(i) Read and understand all directions before using the device,

(ii) Store probe tips under proper conditions,

(iii) Properly sterilize the emitter-detector handpick before each use, and

(iv) Properly maintain and handle the instrument in the specified manner and condition.

[65 FR 18235, Apr. 7, 2000]

return arrow Back to Top

§872.1800   Extraoral source x-ray system.

(a) Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

(b) Classification. Class II.

return arrow Back to Top

§872.1810   Intraoral source x-ray system.

(a) Identification. An intraoral source x-ray system is an electrically powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located inside the mouth. This generic type of device may include patient and equipment supports and component parts.

(b) Classification. Class II.

return arrow Back to Top

§872.1820   Dental x-ray exposure alignment device.

(a) Identification. A dental x-ray exposure alignment device is a device intended to position x-ray film and to align the examination site with the x-ray beam.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, 2001]

return arrow Back to Top

§872.1830   Cephalometer.

(a) Identification. A cephalometer is a device used in dentistry during x-ray procedures. The device is intended to place and to hold a patient's head in a standard position during dental x-rays.

(b) Classification. Class II.

return arrow Back to Top

§872.1840   Dental x-ray position indicating device.

(a) Identification. A dental x-ray position indicating device is a device, such as a collimator, cone, or aperture, that is used in dental radiographic examination. The device is intended to align the examination site with the x-ray beam and to restrict the dimensions of the dental x-ray field by limiting the size of the primary x-ray beam.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, 2001]

return arrow Back to Top

§872.1850   Lead-lined position indicator.

(a) Identification. A lead-lined position indicator is a cone-shaped device lined with lead that is attached to a dental x-ray tube and intended to aid in positioning the tube, to prevent the misfocusing of the x-rays by absorbing divergent radiation, and to prevent leakage of radiation.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, 2001]

return arrow Back to Top

§872.1870   Sulfide detection device.

(a) Identification. A sulfide detection device is a device consisting of an AC-powered control unit, probe handle, probe tips, cables, and accessories. This device is intended to be used in vivo, to manually measure periodontal pocket probing depths, detect the presence or absence of bleeding on probing, and detect the presence of sulfides in periodontal pockets, as an adjunct in the diagnosis of periodontal diseases in adult patients.

(b) Classification. Class II (special controls) prescription use in accordance with §801.109 of this chapter; conformance with recognized standards of biocompatibility, electrical safety, and sterility; clinical and analytical performance testing, and proper labeling.

[63 FR 59717, Nov. 5, 1998]

return arrow Back to Top

§872.1905   Dental x-ray film holder.

(a) Identification. A dental x-ray film holder is a device intended to position and to hold x-ray film inside the mouth.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §872.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exceptions of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, 2001]

return arrow Back to Top

§872.2050   Dental sonography device.

(a) Dental sonography device for monitoring—(1) Identification. A dental sonography device for monitoring is an electrically powered device, intended to be used to monitor temporomandibular joint sounds. The device detects and records sounds made by the temporomandibular joint.

(2) Classification. Class I. The device is exempt from the premarket notification provisions of subpart E of part 807 of this chapter subject to §872.9.

(b) Dental sonography device for interpretation and diagnosis—(1) Identification. A dental sonography device for interpretation and diagnosis is an electrically powered device, intended to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. The device detects, records, displays, and stores sounds made by the temporomandibular joint during jaw movement. The device interprets these sounds to generate meaningful output, either directly or by connection to a personal computer. The device may be part of a system of devices, contributing joint sound information to be considered with data from other diagnostic components.

(2) Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.”

[68 FR 67367, Dec. 2, 2003]

return arrow Back to Top

§872.2060   Jaw tracking device.

(a) Jaw tracking device for monitoring mandibular jaw positions relative to the maxilla—(1) Identification. A jaw tracking device for monitoring mandibular jaw positions relative to the maxilla is a nonpowered or electrically powered device that measures and records anatomical distances and angles in three dimensional space, to determine the relative position of the mandible with respect to the location and position of the maxilla, while at rest and during jaw movement.

(2) Classification. Class I (general controls). The device is exempt from the premarket notification provisions of subpart E of part 807 of this chapter subject to §872.9.

(b) Jaw tracking device for interpretation of mandibular jaw positions for the diagnosis—(1) Identification. A jaw tracking device for interpretation of mandibular jaw positions relative to the maxilla for the diagnosis of temporomandibular joint disorders and associated orofacial pain is a nonpowered or electrically powered device that measures and records anatomical distances and angles to determine the relative position of the mandible in three dimensional space, with respect to the location and position of the maxilla, while at rest and during jaw movement. The device records, displays, and stores information about jaw position. The device interprets jaw position to generate meaningful output, either directly or by connection to a personal computer. The device may be a part of a system of devices, contributing jaw position information to be considered with data from other diagnostic components.

(2) Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Dental Sonography and Jaw Tracking Devices.”

[68 FR 67367, Dec. 2, 2003]

return arrow Back to Top

Need assistance?