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FDA 510(k)

SOLVENEX I-0

K-Number: K771974 · 1978-01-12

ApplicantDen-Mat Corp.
Decision Date1978-01-12
Product CodeKZP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLVENEX I-0 is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Corp.. It received FDA 510(k) clearance on 1978-01-12 under 510(k) number K771974. The device is classified under product code KZP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLVENEX I-0?

SOLVENEX I-0 is a medical device that received FDA 510(k) clearance on 1978-01-12. The listed applicant is Den-Mat Corp.. The 510(k) number is K771974.

When did SOLVENEX I-0 receive FDA 510(k) clearance?

SOLVENEX I-0 received FDA 510(k) clearance on 1978-01-12, under 510(k) number K771974.

Who is the listed applicant for SOLVENEX I-0?

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

What is the FDA product code for SOLVENEX I-0?

The FDA product code for SOLVENEX I-0 is KZP.

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Other records listing Den-Mat 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.

K9831061ST IMPRESSIONK895731DEN-MAT CERINATE PORCELAINK895269DEN-MAT LAMI-QUICKK881918LIGHT-CURED ZIONOMER CEMENTK875351DEN-MAT PORETCH (PORCELAIN ETCHANT)K872510DEN-MAT TENURE

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Related Devices (Code: KZP)

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.

K920843TOOTH CONDITIONERConfi-Dental Products Co.

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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