Title 21

SECTION 872.6730

872.6730 Endodontic dry heat sterilizer.

§ 872.6730 Endodontic dry heat sterilizer.

(a) Identification. An endodontic dry heat sterilizer is a device intended to sterilize endodontic and other dental instruments by the application of dry heat. The heat is supplied through glass beads which have been heated by electricity.

(b) Classification. Class III.

(c) Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before April 21, 1997, for any endodontic dry heat sterilizer that was in commercial distribution before May 28, 1976, or that has on or before April 21, 1997, been found to be substantially equivalent to the endodontic dry heat sterilizer that was in commercial distribution before May 28, 1976. Any other endodontic dry heat sterilizer shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

[52 FR 30097, Aug. 12, 1987, as amended at 62 FR 2902, Jan. 21, 1997; 62 FR 31512, June 10, 1997]

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