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FDA 510(k)

EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL

K-Number: K902531 · 1990-07-13

ApplicantG-C Intl. Corp.
Decision Date1990-07-13
Product CodeEGW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL 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 1990-07-13 under 510(k) number K902531. The device is classified under product code EGW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL?

EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1990-07-13. The listed applicant is G-C Intl. Corp.. The 510(k) number is K902531.

When did EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL receive FDA 510(k) clearance?

EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL received FDA 510(k) clearance on 1990-07-13, under 510(k) number K902531.

Who is the listed applicant for EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL?

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 EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL?

The FDA product code for EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL is EGW.

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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 CUREK896883GC CERVICAL CEMENTK895976TOOTH SHADE RESINK892806TUF-COAT

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Related Devices (Code: EGW)

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.

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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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