NYE · Class I — Low Risk (general controls) · Dental · 21 CFR 872.3980
Classification
FDA Product Code
NYE
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 872.3980
Review panel
DE
Medical specialty
Dental
Submission type
7
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.