StacksVerified U.S. regulatory reference

21 CFR §878.3925

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
  1. (a)Identification. A plastic surgery kit and accessories is a device intended to be used to reconstruct maxillofacial deficiencies. The kit contains surgical instruments and materials used to make maxillofacial impressions before molding an external prosthesis.
  2. (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 § 878.9.