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FDA 510(k)

SINGLES

K-Number: K930453 · 1993-05-27

ApplicantNexadental
Decision Date1993-05-27
Product CodeECI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SINGLES is the device name listed in this FDA 510(k) record. The listed applicant is Nexadental. It received FDA 510(k) clearance on 1993-05-27 under 510(k) number K930453. The device is classified under product code ECI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLES?

SINGLES is a medical device that received FDA 510(k) clearance on 1993-05-27. The listed applicant is Nexadental. The 510(k) number is K930453.

When did SINGLES receive FDA 510(k) clearance?

SINGLES received FDA 510(k) clearance on 1993-05-27, under 510(k) number K930453.

Who is the listed applicant for SINGLES?

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

What is the FDA product code for SINGLES?

The FDA product code for SINGLES is ECI.

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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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