510(k) K171713

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

K171713 is an FDA 510(k) premarket notification submitted by Jjgc Industria E Comercio DE Materiais Dentarios S.A. for the device "Neodent Instrument Kits". The FDA issued a decision of Substantially Equivalent on Apr 5, 2018. 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
Apr 5, 2018
Date Received
Jun 9, 2017
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)