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FDA 510(k)

DENTURE RESIN

K-Number: K890830 · 1989-05-01

ApplicantG-C Intl. Corp.
Decision Date1989-05-01
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTURE RESIN is the device name listed in this FDA 510(k) record. The listed applicant is G-C Intl. Corp.. It received FDA 510(k) clearance on 1989-05-01 under 510(k) number K890830. 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 DENTURE RESIN?

DENTURE RESIN is a medical device that received FDA 510(k) clearance on 1989-05-01. The listed applicant is G-C Intl. Corp.. The 510(k) number is K890830.

When did DENTURE RESIN receive FDA 510(k) clearance?

DENTURE RESIN received FDA 510(k) clearance on 1989-05-01, under 510(k) number K890830.

Who is the listed applicant for DENTURE RESIN?

The FDA 510(k) record lists G-C Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTURE RESIN?

The FDA product code for DENTURE RESIN is EBI.

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Other records listing G-C Intl. Corp. 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.

K913175MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULESK913884FUJI II LCK901999FUJI LINING CEMENT LIGHT CUREK902531EXAPHASE, SINGLE PHASE IMPRESSION MATERIALK896883GC CERVICAL CEMENTK895976TOOTH SHADE RESIN

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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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