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FDA 510(k)

FIXTECTOR

K-Number: K864572 · 1987-02-12

ApplicantProdent Intl., Inc.
Decision Date1987-02-12
Product CodeEFH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIXTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Prodent Intl., Inc.. It received FDA 510(k) clearance on 1987-02-12 under 510(k) number K864572. The device is classified under product code EFH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXTECTOR?

FIXTECTOR is a medical device that received FDA 510(k) clearance on 1987-02-12. The listed applicant is Prodent Intl., Inc.. The 510(k) number is K864572.

When did FIXTECTOR receive FDA 510(k) clearance?

FIXTECTOR received FDA 510(k) clearance on 1987-02-12, under 510(k) number K864572.

Who is the listed applicant for FIXTECTOR?

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

What is the FDA product code for FIXTECTOR?

The FDA product code for FIXTECTOR is EFH.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Prodent Intl., 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.

K904296LYSTA HYGIENIST III SCALER

Related Devices (Code: EFH)

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.

K965026PFINGST PRESSURE PASTEPfingst & Co., Inc.K912632OCCLUDEPascal Co., Inc.K911259HYDENTPascal Co., Inc.K870032REVISED T-SCAN SYSTEMSentek, Inc.K832647ARTICULATING PAPERArdent Intl., Inc.K833132MUCOSAL ADJUSTMENT PASTE LIQUID SPRAYMyo-Tronics Research, Inc.

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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