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FDA 510(k)

Guided Surgery Kit Cases

K-Number: K241492 · 2024-08-23

ApplicantJJGC Indústria e Comércio de Materiais Dentários S.A.
Decision Date2024-08-23
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Guided Surgery Kit Cases is the device name listed in this FDA 510(k) record. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. It received FDA 510(k) clearance on 2024-08-23 under 510(k) number K241492. 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 Guided Surgery Kit Cases?

Guided Surgery Kit Cases is a medical device that received FDA 510(k) clearance on 2024-08-23. The listed applicant is JJGC Indústria e Comércio de Materiais Dentários S.A.. The 510(k) number is K241492.

When did Guided Surgery Kit Cases receive FDA 510(k) clearance?

Guided Surgery Kit Cases received FDA 510(k) clearance on 2024-08-23, under 510(k) number K241492.

Who is the listed applicant for Guided Surgery Kit Cases?

The FDA 510(k) record lists JJGC Indústria e Comércio de Materiais Dentários S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Guided Surgery Kit Cases?

The FDA product code for Guided Surgery Kit Cases is KCT.

Other records listing JJGC Indústria e Comércio de Materiais Dentários 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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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