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FDA 510(k)

HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE

K-Number: K850014 · 1985-01-23

ApplicantMedi-Dent American, Inc.
Decision Date1985-01-23
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE is the device name listed in this FDA 510(k) record. The listed applicant is Medi-Dent American, Inc.. It received FDA 510(k) clearance on 1985-01-23 under 510(k) number K850014. The device is classified under product code EBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE?

HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE is a medical device that received FDA 510(k) clearance on 1985-01-23. The listed applicant is Medi-Dent American, Inc.. The 510(k) number is K850014.

When did HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE receive FDA 510(k) clearance?

HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE received FDA 510(k) clearance on 1985-01-23, under 510(k) number K850014.

Who is the listed applicant for HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE?

The FDA 510(k) record lists Medi-Dent American, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE?

The FDA product code for HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE is EBH.

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Related Devices (Code: EBH)

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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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