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FDA 510(k)

IMPRESSION COMPOUND

K-Number: K110378 · 2011-04-05

ApplicantSpofadental
Decision Date2011-04-05
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPRESSION COMPOUND is the device name listed in this FDA 510(k) record. The listed applicant is Spofadental. It received FDA 510(k) clearance on 2011-04-05 under 510(k) number K110378. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPRESSION COMPOUND?

IMPRESSION COMPOUND is a medical device that received FDA 510(k) clearance on 2011-04-05. The listed applicant is Spofadental. The 510(k) number is K110378.

When did IMPRESSION COMPOUND receive FDA 510(k) clearance?

IMPRESSION COMPOUND received FDA 510(k) clearance on 2011-04-05, under 510(k) number K110378.

Who is the listed applicant for IMPRESSION COMPOUND?

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

What is the FDA product code for IMPRESSION COMPOUND?

The FDA product code for IMPRESSION COMPOUND is ELW.

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Related Devices (Code: ELW)

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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