Neodent Instrument Kit Cases

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

JJGC Industria E Comercio De Materiais Dentarios S.A.

The following data is part of a premarket notification filed by Jjgc Industria E Comercio De Materiais Dentarios S.a. with the FDA for Neodent Instrument Kit Cases.

Pre-market Notification Details

Device IDK192670
510k NumberK192670
Device Name:Neodent Instrument Kit Cases
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant JJGC Industria E Comercio De Materiais Dentarios S.A. Av. Juscelino Kubitschek De Oliveira, 3291 - CIC Curitiba,  BR 81270-200
ContactLuiza Vaccari Toppel
CorrespondentJennifer M. Jackson
Straumann USA, LLC 60 Minuteman Road Andover,  MA  01810
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-25
Decision Date2019-12-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07899878039556 K192670 000
07899878032120 K192670 000
07899878032137 K192670 000
07899878033578 K192670 000
07899878033585 K192670 000
07899878045571 K192670 000
07899878045588 K192670 000
07899878045595 K192670 000
07899878045632 K192670 000
07899878045939 K192670 000
07899878054382 K192670 000
07899878031628 K192670 000

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