U.S. Code of Federal Regulations
Regulations most recently checked for updates: Aug 28, 2025
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All TitlesTitle 21Chapter IPart 878Subpart D - Subpart D—Prosthetic Devices
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(a) Identification. An external prosthesis adhesive is a silicone-type adhesive intended to be used to fasten to the body an external aesthetic restoration prosthesis, such as an artificial nose.
(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 § 878.9.
