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NYEClass I

Fixture Mount Kit

21 CFR 872.3980 / Dental
FDA source (opens on fda.gov)

NYE is the FDA product code for Fixture Mount Kit, a class I device type, regulated under 21 CFR 872.3980. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NYE
Device name
Fixture Mount Kit
FDA 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.
Regulation
21 CFR 872.3980
Device class
Class I
Review panel
Dental
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order