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FDA 510(k)

T.R.S.: TOOTH REPLACEMENT SYSTEM

K-Number: K891119 · 1989-04-17

ApplicantHealth Technology of America, Inc.
Decision Date1989-04-17
Product CodeEGG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

T.R.S.: TOOTH REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Health Technology of America, Inc.. It received FDA 510(k) clearance on 1989-04-17 under 510(k) number K891119. The device is classified under product code EGG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T.R.S.: TOOTH REPLACEMENT SYSTEM?

T.R.S.: TOOTH REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1989-04-17. The listed applicant is Health Technology of America, Inc.. The 510(k) number is K891119.

When did T.R.S.: TOOTH REPLACEMENT SYSTEM receive FDA 510(k) clearance?

T.R.S.: TOOTH REPLACEMENT SYSTEM received FDA 510(k) clearance on 1989-04-17, under 510(k) number K891119.

Who is the listed applicant for T.R.S.: TOOTH REPLACEMENT SYSTEM?

The FDA 510(k) record lists Health Technology of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T.R.S.: TOOTH REPLACEMENT SYSTEM?

The FDA product code for T.R.S.: TOOTH REPLACEMENT SYSTEM is EGG.

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Related Devices (Code: EGG)

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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