NYE

Fixture Mount Kit

Product code

NYE

Device name

Fixture Mount Kit

Device class

Class 1

21 CFR

21 CFR 872.3980

Medical specialty

Dental

Marketing pathway

Enforcement Discretion

FDA classification definition

Fixture dental mount kit may contain hand instruments, drill bits, and screw drivers. This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Definition text from the FDA device classification database (U.S. federal government work, public domain).