Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Neodent Instrument Kits

K-Number: K171713 · 2018-04-05

Decision Date2018-04-05
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Neodent Instrument 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 2018-04-05 under 510(k) number K171713. 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 Instrument Kits?

Neodent Instrument Kits is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K171713.

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

Neodent Instrument Kits received FDA 510(k) clearance on 2018-04-05, under 510(k) number K171713.

Who is the listed applicant for Neodent Instrument 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 Instrument Kits?

The FDA product code for Neodent Instrument Kits is KCT.

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

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.

View all 28 devices →

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.

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.