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FDA 510(k)

APPOLLO 3 ALLOY

K-Number: K032320 · 2003-10-01

ApplicantDentsply International
Decision Date2003-10-01
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

APPOLLO 3 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 2003-10-01 under 510(k) number K032320. 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 APPOLLO 3 ALLOY?

APPOLLO 3 ALLOY is a medical device that received FDA 510(k) clearance on 2003-10-01. The listed applicant is Dentsply International. The 510(k) number is K032320.

When did APPOLLO 3 ALLOY receive FDA 510(k) clearance?

APPOLLO 3 ALLOY received FDA 510(k) clearance on 2003-10-01, under 510(k) number K032320.

Who is the listed applicant for APPOLLO 3 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 APPOLLO 3 ALLOY?

The FDA product code for APPOLLO 3 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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