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FDA 510(k)

DENTAL ACRYLIC POLYMERS

K-Number: K850650 · 1985-05-22

ApplicantCole Polymers , Ltd.
Decision Date1985-05-22
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL ACRYLIC POLYMERS is the device name listed in this FDA 510(k) record. The listed applicant is Cole Polymers , Ltd.. It received FDA 510(k) clearance on 1985-05-22 under 510(k) number K850650. 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 DENTAL ACRYLIC POLYMERS?

DENTAL ACRYLIC POLYMERS is a medical device that received FDA 510(k) clearance on 1985-05-22. The listed applicant is Cole Polymers , Ltd.. The 510(k) number is K850650.

When did DENTAL ACRYLIC POLYMERS receive FDA 510(k) clearance?

DENTAL ACRYLIC POLYMERS received FDA 510(k) clearance on 1985-05-22, under 510(k) number K850650.

Who is the listed applicant for DENTAL ACRYLIC POLYMERS?

The FDA 510(k) record lists Cole Polymers , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL ACRYLIC POLYMERS?

The FDA product code for DENTAL ACRYLIC POLYMERS is EBI.

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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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