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FDA 510(k)

Neodent Instruments Kits

K-Number: K182865 · 2019-05-07

ApplicantJjgc Industria E Comercio DE Materiais Dentarios S.A.
Decision Date2019-05-07
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Neodent Instruments Kits is the device name listed in this FDA 510(k) record. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2019-05-07 under 510(k) number K182865. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neodent Instruments Kits?

Neodent Instruments Kits is a medical device that received FDA 510(k) clearance on 2019-05-07. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K182865.

When did Neodent Instruments Kits receive FDA 510(k) clearance?

Neodent Instruments Kits received FDA 510(k) clearance on 2019-05-07, under 510(k) number K182865.

Who is the listed applicant for Neodent Instruments Kits?

The FDA 510(k) record lists Jjgc Industria E Comercio DE Materiais Dentarios S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neodent Instruments Kits?

The FDA product code for Neodent Instruments Kits is KCT.

Other records listing Jjgc Industria E Comercio DE Materiais Dentarios S.A. as applicant

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Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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