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FDA 510(k)

MINERVA 58 ALLOY

K-Number: K032318 · 2003-09-30

ApplicantDentsply International
Decision Date2003-09-30
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINERVA 58 ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply International. It received FDA 510(k) clearance on 2003-09-30 under 510(k) number K032318. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINERVA 58 ALLOY?

MINERVA 58 ALLOY is a medical device that received FDA 510(k) clearance on 2003-09-30. The listed applicant is Dentsply International. The 510(k) number is K032318.

When did MINERVA 58 ALLOY receive FDA 510(k) clearance?

MINERVA 58 ALLOY received FDA 510(k) clearance on 2003-09-30, under 510(k) number K032318.

Who is the listed applicant for MINERVA 58 ALLOY?

The FDA 510(k) record lists Dentsply International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINERVA 58 ALLOY?

The FDA product code for MINERVA 58 ALLOY is EJT.

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Other records listing Dentsply International 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.

K122268ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOSK061580ECLIPSE WAX REMOVERK060837IN-OVATION CK053368INTERPROXIMAL REDUCTION SYSTEMK052370CP BRACKET SYSTEMK052097CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE

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Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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