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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 a medical device manufactured by Guilin Fiteeth Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-10-13 under approval 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. It is manufactured by Guilin Fiteeth Medical Instrument Co., Ltd.. The 510(k) number is K212702.

When was IM/ST Fixture System approved by the FDA?

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

What company makes IM/ST Fixture System?

IM/ST Fixture System is manufactured by Guilin Fiteeth Medical Instrument Co., Ltd..

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

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

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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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