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FDA 510(k)

ACUCAM CONCEPT IV FWT, MODEL 110-0185G1

K-Number: K032904 · 2003-10-14

ApplicantDentsply Intl.
Decision Date2003-10-14
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2003-10-14 under 510(k) number K032904. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUCAM CONCEPT IV FWT, MODEL 110-0185G1?

ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 is a medical device that received FDA 510(k) clearance on 2003-10-14. The listed applicant is Dentsply Intl.. The 510(k) number is K032904.

When did ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 receive FDA 510(k) clearance?

ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 received FDA 510(k) clearance on 2003-10-14, under 510(k) number K032904.

Who is the listed applicant for ACUCAM CONCEPT IV FWT, MODEL 110-0185G1?

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

What is the FDA product code for ACUCAM CONCEPT IV FWT, MODEL 110-0185G1?

The FDA product code for ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 is EIA.

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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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