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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR872.3670]
See Related Information on Resin impression tray material. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 872 -- DENTAL DEVICES

Subpart D--Prosthetic Devices

Sec. 872.3670 Resin impression tray material.

(a)Identification. Resin impression tray material is a device intended for use in a two-step dental mold fabricating process. The device consists of a resin material, such as methyl methacrylate, and is used to form a custom impression tray for use in cases in which a preformed impression tray is not suitable, such as the fabrication of crowns, bridges, or full dentures. A preliminary plaster or stone model of the patient's teeth and gums is made. The resin impression tray material is applied to this preliminary study model to form a custom tray. This tray is then filled with impression material and inserted into the patient's mouth to make an impression, from which a final, more precise, model of the patient's mouth is cast.

(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 exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception 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 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001]

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