510(k) K190665

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

K190665 is an FDA 510(k) premarket notification submitted by Jjgc Industria E Comercio DE Materiais Dentarios S.A. for the device "Neodent Instrument Kit Cases". The FDA issued a decision of Substantially Equivalent on Dec 23, 2019. 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
Dec 23, 2019
Date Received
Mar 15, 2019
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)