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FDA 510(k)

DIAMOND D HIGH IMPACT DENTURE ACRYLIC

K-Number: K032773 · 2003-09-23

ApplicantMycone Dental Supply Co., Inc.
Decision Date2003-09-23
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIAMOND D HIGH IMPACT DENTURE ACRYLIC is the device name listed in this FDA 510(k) record. The listed applicant is Mycone Dental Supply Co., Inc.. It received FDA 510(k) clearance on 2003-09-23 under 510(k) number K032773. 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 DIAMOND D HIGH IMPACT DENTURE ACRYLIC?

DIAMOND D HIGH IMPACT DENTURE ACRYLIC is a medical device that received FDA 510(k) clearance on 2003-09-23. The listed applicant is Mycone Dental Supply Co., Inc.. The 510(k) number is K032773.

When did DIAMOND D HIGH IMPACT DENTURE ACRYLIC receive FDA 510(k) clearance?

DIAMOND D HIGH IMPACT DENTURE ACRYLIC received FDA 510(k) clearance on 2003-09-23, under 510(k) number K032773.

Who is the listed applicant for DIAMOND D HIGH IMPACT DENTURE ACRYLIC?

The FDA 510(k) record lists Mycone Dental Supply Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAMOND D HIGH IMPACT DENTURE ACRYLIC?

The FDA product code for DIAMOND D HIGH IMPACT DENTURE ACRYLIC is EBI.

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Other records listing Mycone Dental Supply Co., 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.

K112597SEITY 37% PHOSPHORIC ACID ETCHANT GELK093380MIZZY EXPRESS

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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