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FDA 510(k)

IGI-SYSTEM

K-Number: K052840 · 2005-12-16

ApplicantDenx Advanced Dental Systems
Decision Date2005-12-16
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

IGI-SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Denx Advanced Dental Systems. It received FDA 510(k) clearance on 2005-12-16 under 510(k) number K052840. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IGI-SYSTEM?

IGI-SYSTEM is a medical device that received FDA 510(k) clearance on 2005-12-16. The listed applicant is Denx Advanced Dental Systems. The 510(k) number is K052840.

When did IGI-SYSTEM receive FDA 510(k) clearance?

IGI-SYSTEM received FDA 510(k) clearance on 2005-12-16, under 510(k) number K052840.

Who is the listed applicant for IGI-SYSTEM?

The FDA 510(k) record lists Denx Advanced Dental Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IGI-SYSTEM?

The FDA product code for IGI-SYSTEM is HAW.

Related Clinical Trials

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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Other records listing Denx Advanced Dental Systems 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.

K023424IGI-SYSTEM

Related Devices (Code: HAW)

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.

K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc.K261932Leksell® Vantage Stereotactic SystemElekta Solutions ABK253663Zeta Navigation SystemZeta Surgical, Inc.K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc.K231897NeuroAlign softwareMedivis, Inc.K251317SOLOPASS 2.0 SystemIntravent Medical Partners

Official Source

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

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