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FDA 510(k)

PREFORMED TOOTH POSITIONER

K-Number: K780619 · 1978-06-28

ApplicantTp Laboratories, Inc.
Decision Date1978-06-28
Product CodeKMY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREFORMED TOOTH POSITIONER is the device name listed in this FDA 510(k) record. The listed applicant is Tp Laboratories, Inc.. It received FDA 510(k) clearance on 1978-06-28 under 510(k) number K780619. The device is classified under product code KMY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREFORMED TOOTH POSITIONER?

PREFORMED TOOTH POSITIONER is a medical device that received FDA 510(k) clearance on 1978-06-28. The listed applicant is Tp Laboratories, Inc.. The 510(k) number is K780619.

When did PREFORMED TOOTH POSITIONER receive FDA 510(k) clearance?

PREFORMED TOOTH POSITIONER received FDA 510(k) clearance on 1978-06-28, under 510(k) number K780619.

Who is the listed applicant for PREFORMED TOOTH POSITIONER?

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

What is the FDA product code for PREFORMED TOOTH POSITIONER?

The FDA product code for PREFORMED TOOTH POSITIONER is KMY.

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Related Devices (Code: KMY)

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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