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FDA 510(k)

PERMAFLEX PERMANENT SOFT DENTURE RELINER

K-Number: K925062 · 1993-03-31

ApplicantProtech Professional Products, Inc.
Decision Date1993-03-31
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMAFLEX PERMANENT SOFT DENTURE RELINER is the device name listed in this FDA 510(k) record. The listed applicant is Protech Professional Products, Inc.. It received FDA 510(k) clearance on 1993-03-31 under 510(k) number K925062. 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 PERMAFLEX PERMANENT SOFT DENTURE RELINER?

PERMAFLEX PERMANENT SOFT DENTURE RELINER is a medical device that received FDA 510(k) clearance on 1993-03-31. The listed applicant is Protech Professional Products, Inc.. The 510(k) number is K925062.

When did PERMAFLEX PERMANENT SOFT DENTURE RELINER receive FDA 510(k) clearance?

PERMAFLEX PERMANENT SOFT DENTURE RELINER received FDA 510(k) clearance on 1993-03-31, under 510(k) number K925062.

Who is the listed applicant for PERMAFLEX PERMANENT SOFT DENTURE RELINER?

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

What is the FDA product code for PERMAFLEX PERMANENT SOFT DENTURE RELINER?

The FDA product code for PERMAFLEX PERMANENT SOFT DENTURE RELINER is EBI.

Related Clinical Trials

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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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