(a) Low-energy DC-defibrillator-(1) Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.

(2) Classification. Class II (performance standards).

(b) High-energy DC-defibrillator—(1) Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.

(2) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See & 870.3.

[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]

§ 870.5325 Defibrillator tester.

(a) Identification. A defibrillator tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load. Some testers also provide waveform information.

(b) Classification. Class II (performance standards).

§ 870.5550

External transcutaneous cardiac pacemaker (noninvasive).

(a) Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval for the device described in paragraph (b)(1). See § 870.3.

[45 FR 7907-7971, Feb. 5, 1980, as amended at 52 FR 17737, May 11, 1987]

872.3520 OTC denture cleanser. 872.3530 Mechanical denture cleaner. 872.3540 OTC denture cushion or pad. 872.3560 OTC denture reliner. 872.3570 OTC denture repair kit.

872.3580 Preformed gold denture tooth. 872.3590 Preformed plastic denture tooth. 872.3600 Partially fabricated denture kit. 872.3640 Endosseous implant.

872.3645 Subperiosteal implant material. 872.3660 Impression material.

872.3670 Resin impression tray material. 872.3680 Polytetrafluoroethylene (PTFE)

vitreous carbon material.

872.3690 Tooth shade resin material. 872.3700 Dental mercury.

872.3710 Base metal alloy.

872.3730 Pantograph.

872.3740 Retentive and splinting pin.

872.3750 Bracket adhesive resin and tooth

Subpart A-General Provisions

§ 872.1 Scope.

(a) This part sets forth the classification of dental devices intended for human use that are in commercial distribution.

(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under Part 807 cannot show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87.

(c) To avoid duplicative listings, a dental device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed in one subpart only.

(d) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21 unless otherwise noted.

§ 872.3 Effective dates of requirement for premarket approval.

A device included in this part that is classified into class III (premarket approval) shall not be commercially distributed after the date shown in the regulation classifying the device unless the manufacturer has an approval under section 515 of the act (unless an exemption has been granted under section 520(g)(2) of the act). An approval under section 515 of the act consists of FDA's issuance of an order approving an application for premarket approval (PMA) for the device or declaring completed a product development protocol (PDP) for the device.

341-073 0-93--10

515 of the act before commercial distribution.

30th full calendar month after the regulation that classifies the device into class III is effective, whichever is later. See section 501(f)(2)(B) of the act. Accordingly, unless an effective date of the requirement for premarket approval is shown in the regulation for a device classified into class III in this part, the device may be commercially distributed without FDA's issuance of an order approving a PMA or declaring completed a PDP for the device. If FDA promulgates a regulation under section 515(b) of the act requiring premarket approval for a device, section 501(f)(1)(A) of the act applies to the device.

(b) Any new, not substantially equivalent, device introduced into commercial distribution on or after May 28, 1976, including a device formerly marketed that has been substantially altered, is classified by statute (section 513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or declaring completed a PDP for the device before the device is commercially distributed unless it is reclassified. If FDA knows that a device being commercially distributed may be a "new" device as defined in this section because of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

(c) A device identified in a regulation in this part that is classified into class III and that is subject to the transitional provisions of section 520(1) of the act is automatically classified by statute into class III and must have an approval under section 515 of the act before being commercially distributed. Accordingly, the regulation for such a class III transitional device states that as of the enactment date of the amendments, May 28, 1976, the device must have an approval under section

section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). The Food and Drug Administration's (FDA's) decision to grant an exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I device is based upon the existing and reasonably foreseeable characteristics of commercially distributed devices

within that generic type. Because FDA cannot anticipate every change in intended use or characteristic that could significantly affect a device's safety or effectiveness, manufacturers of any commercially distributed class I device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device when:

(a) The device is intended for a use different from its intended use before May 28, 1976, or the device is intended for a use different from the intended use of a preamendments device to which it had been determined to be substantially equivalent; e.g., the device is intended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only; or

(b) The modified device operates using a different fundamental scientific technology than that in use in the device before May 28, 1976; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or identifies infectious agents by using a deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology rather than culture or immunoassay technology.

[54 FR 13829, Apr. 5, 1989]

Subpart B-Diagnostic Devices 8872.1500 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.

§ 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.

§ 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) I. Classification. Class The device is exempt from the premarket notification procedures in Subpart E of Part 807 of this chapter.

[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5, 1989]

§ 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.

8872.1800 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 Xray 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.

8872.1810 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.

§ 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 Xray beam.

(b) Classification. Class I.

§ 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 Xrays.

(b) Classification. Class II.

§ 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 Xray 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 II.

§ 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 II.

§ 872.1905 Dental X-ray film holder.

(a) Identification. A dental X-ray film holder is a device intended to po