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FDA 510(k)

THE SMILE MACHINE

K-Number: K891694 · 1989-06-16

ApplicantBrilliant Industries, Inc.
Decision Date1989-06-16
Product CodeJEQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE SMILE MACHINE is the device name listed in this FDA 510(k) record. The listed applicant is Brilliant Industries, Inc.. It received FDA 510(k) clearance on 1989-06-16 under 510(k) number K891694. The device is classified under product code JEQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE SMILE MACHINE?

THE SMILE MACHINE is a medical device that received FDA 510(k) clearance on 1989-06-16. The listed applicant is Brilliant Industries, Inc.. The 510(k) number is K891694.

When did THE SMILE MACHINE receive FDA 510(k) clearance?

THE SMILE MACHINE received FDA 510(k) clearance on 1989-06-16, under 510(k) number K891694.

Who is the listed applicant for THE SMILE MACHINE?

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

What is the FDA product code for THE SMILE MACHINE?

The FDA product code for THE SMILE MACHINE is JEQ.

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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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