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FDA 510(k)

IMPRESSION TRAY, MDDS CUSTOM

K-Number: K782153 · 1979-02-26

ApplicantChayet and Sonnenrich, P.C.
Decision Date1979-02-26
Product CodeEBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPRESSION TRAY, MDDS CUSTOM is the device name listed in this FDA 510(k) record. The listed applicant is Chayet and Sonnenrich, P.C.. It received FDA 510(k) clearance on 1979-02-26 under 510(k) number K782153. 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 IMPRESSION TRAY, MDDS CUSTOM?

IMPRESSION TRAY, MDDS CUSTOM is a medical device that received FDA 510(k) clearance on 1979-02-26. The listed applicant is Chayet and Sonnenrich, P.C.. The 510(k) number is K782153.

When did IMPRESSION TRAY, MDDS CUSTOM receive FDA 510(k) clearance?

IMPRESSION TRAY, MDDS CUSTOM received FDA 510(k) clearance on 1979-02-26, under 510(k) number K782153.

Who is the listed applicant for IMPRESSION TRAY, MDDS CUSTOM?

The FDA 510(k) record lists Chayet and Sonnenrich, P.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPRESSION TRAY, MDDS CUSTOM?

The FDA product code for IMPRESSION TRAY, MDDS CUSTOM is EBH.

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Related Devices (Code: EBH)

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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