510(k) K202515

NUVO Implant System – NUVO Instrument Kit Cases by Jjgc Industria E Comercio DE Materiais Dentarios S.A. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2020
Date Received
September 1, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type