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FDA 510(k)

NUVO Implant System – NUVO Instrument Kit Cases

K-Number: K202515 · 2020-11-24

Decision Date2020-11-24
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NUVO Implant System – NUVO Instrument Kit Cases 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 2020-11-24 under 510(k) number K202515. 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 NUVO Implant System – NUVO Instrument Kit Cases?

NUVO Implant System – NUVO Instrument Kit Cases is a medical device that received FDA 510(k) clearance on 2020-11-24. The listed applicant is Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K202515.

When did NUVO Implant System – NUVO Instrument Kit Cases receive FDA 510(k) clearance?

NUVO Implant System – NUVO Instrument Kit Cases received FDA 510(k) clearance on 2020-11-24, under 510(k) number K202515.

Who is the listed applicant for NUVO Implant System – NUVO Instrument Kit Cases?

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 NUVO Implant System – NUVO Instrument Kit Cases?

The FDA product code for NUVO Implant System – NUVO Instrument Kit Cases 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

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