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FDA 510(k)

SMILE WITH CONFIDENCE

K-Number: K971002 · 1997-07-15

ApplicantLloyd V. Ziemendorf
Decision Date1997-07-15
Product CodeEHS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SMILE WITH CONFIDENCE is the device name listed in this FDA 510(k) record. The listed applicant is Lloyd V. Ziemendorf. It received FDA 510(k) clearance on 1997-07-15 under 510(k) number K971002. The device is classified under product code EHS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMILE WITH CONFIDENCE?

SMILE WITH CONFIDENCE is a medical device that received FDA 510(k) clearance on 1997-07-15. The listed applicant is Lloyd V. Ziemendorf. The 510(k) number is K971002.

When did SMILE WITH CONFIDENCE receive FDA 510(k) clearance?

SMILE WITH CONFIDENCE received FDA 510(k) clearance on 1997-07-15, under 510(k) number K971002.

Who is the listed applicant for SMILE WITH CONFIDENCE?

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

What is the FDA product code for SMILE WITH CONFIDENCE?

The FDA product code for SMILE WITH CONFIDENCE is EHS.

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Related Devices (Code: EHS)

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

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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