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FDA 510(k)

TCS UNBREAKABLE

K-Number: K053060 · 2006-07-20

ApplicantThermoplastic Comfort Systems, Inc.
Decision Date2006-07-20
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TCS UNBREAKABLE is the device name listed in this FDA 510(k) record. The listed applicant is Thermoplastic Comfort Systems, Inc.. It received FDA 510(k) clearance on 2006-07-20 under 510(k) number K053060. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TCS UNBREAKABLE?

TCS UNBREAKABLE is a medical device that received FDA 510(k) clearance on 2006-07-20. The listed applicant is Thermoplastic Comfort Systems, Inc.. The 510(k) number is K053060.

When did TCS UNBREAKABLE receive FDA 510(k) clearance?

TCS UNBREAKABLE received FDA 510(k) clearance on 2006-07-20, under 510(k) number K053060.

Who is the listed applicant for TCS UNBREAKABLE?

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

What is the FDA product code for TCS UNBREAKABLE?

The FDA product code for TCS UNBREAKABLE is EBI.

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 Thermoplastic Comfort Systems, 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.

K123396I.FLEX BY TCS

Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, 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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