21 C.F.R. § 878.3590

Ear prosthesis.

Last amended: 2016Year: 2026Length: 24 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 878.3590 (2026)

(a) Identification. An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear. (b) Classification. Class II.
21 C.F.R. § 878.3590: Ear prosthesis. | Justis AI