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FDA 510(k)

TRUETECH MEDICAL, INC. DENTURE CUPS

K-Number: K871160 · 1987-06-23

ApplicantZenex Medical, Inc.
Decision Date1987-06-23
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRUETECH MEDICAL, INC. DENTURE CUPS is the device name listed in this FDA 510(k) record. The listed applicant is Zenex Medical, Inc.. It received FDA 510(k) clearance on 1987-06-23 under 510(k) number K871160. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUETECH MEDICAL, INC. DENTURE CUPS?

TRUETECH MEDICAL, INC. DENTURE CUPS is a medical device that received FDA 510(k) clearance on 1987-06-23. The listed applicant is Zenex Medical, Inc.. The 510(k) number is K871160.

When did TRUETECH MEDICAL, INC. DENTURE CUPS receive FDA 510(k) clearance?

TRUETECH MEDICAL, INC. DENTURE CUPS received FDA 510(k) clearance on 1987-06-23, under 510(k) number K871160.

Who is the listed applicant for TRUETECH MEDICAL, INC. DENTURE CUPS?

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

What is the FDA product code for TRUETECH MEDICAL, INC. DENTURE CUPS?

The FDA product code for TRUETECH MEDICAL, INC. DENTURE CUPS is ELM.

Related Clinical Trials

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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Other records listing Zenex Medical, Inc. as applicant

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.

K864298ZENEX MEDICAL, INC. GAUZE SPONGES

Related Devices (Code: ELM)

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.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122925NEW STETIC ARTIFICIAL TEETHNew SteticK122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AG

Official Source

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