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FDA 510(k)

IMPAK ACRYLIC REPAIR RESIN LIQUID

K-Number: K033020 · 2003-12-19

ApplicantCmp Industries, LLC
Decision Date2003-12-19
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMPAK ACRYLIC REPAIR RESIN LIQUID is the device name listed in this FDA 510(k) record. The listed applicant is Cmp Industries, LLC. It received FDA 510(k) clearance on 2003-12-19 under 510(k) number K033020. 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 IMPAK ACRYLIC REPAIR RESIN LIQUID?

IMPAK ACRYLIC REPAIR RESIN LIQUID is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Cmp Industries, LLC. The 510(k) number is K033020.

When did IMPAK ACRYLIC REPAIR RESIN LIQUID receive FDA 510(k) clearance?

IMPAK ACRYLIC REPAIR RESIN LIQUID received FDA 510(k) clearance on 2003-12-19, under 510(k) number K033020.

Who is the listed applicant for IMPAK ACRYLIC REPAIR RESIN LIQUID?

The FDA 510(k) record lists Cmp Industries, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMPAK ACRYLIC REPAIR RESIN LIQUID?

The FDA product code for IMPAK ACRYLIC REPAIR RESIN LIQUID is EBI.

Related Clinical Trials

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Other records listing Cmp Industries, LLC 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.

K170423DentureID MicrochipK170375Nobilplast Denture ResinK072851POLYSTAR 79 DENTURE BASE RESINK072402FLEX-STAR VK953594VULCANK902972FLEXOR (DENTURE ACRYLIC RELINE MATERIAL)

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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