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FDA 510(k)

IM/ST Fixture System

K-Number: K212702 · 2022-10-13

ApplicantGuilin Fiteeth Medical Instrument Co., Ltd.
Decision Date2022-10-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IM/ST Fixture System is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Fiteeth Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-10-13 under 510(k) number K212702. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IM/ST Fixture System?

IM/ST Fixture System is a medical device that received FDA 510(k) clearance on 2022-10-13. The listed applicant is Guilin Fiteeth Medical Instrument Co., Ltd.. The 510(k) number is K212702.

When did IM/ST Fixture System receive FDA 510(k) clearance?

IM/ST Fixture System received FDA 510(k) clearance on 2022-10-13, under 510(k) number K212702.

Who is the listed applicant for IM/ST Fixture System?

The FDA 510(k) record lists Guilin Fiteeth Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IM/ST Fixture System?

The FDA product code for IM/ST Fixture System is DZE.

Related Devices (Code: DZE)

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

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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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