510(k) K203618

Neodent EasyGuide Kit Cases by Jjgc Industria E Comercio DE Materiais Dentarios S.A. — Product Code KCT

K203618 is an FDA 510(k) premarket notification submitted by Jjgc Industria E Comercio DE Materiais Dentarios S.A. for the device "Neodent EasyGuide Kit Cases". The FDA issued a decision of Substantially Equivalent on Mar 9, 2021. The device falls under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories), a Class II device regulated under 21 CFR 880.6850. Jjgc Industria E Comercio DE Materiais Dentarios S.A. has 27 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 9, 2021
Date Received
Dec 11, 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
510(k)