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FDA 510(k)

GOTHIC ARCH TRACING

K-Number: K771176 · 1977-08-16

ApplicantDentsply Intl.
Decision Date1977-08-16
Product CodeKZO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GOTHIC ARCH TRACING is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1977-08-16 under 510(k) number K771176. The device is classified under product code KZO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOTHIC ARCH TRACING?

GOTHIC ARCH TRACING is a medical device that received FDA 510(k) clearance on 1977-08-16. The listed applicant is Dentsply Intl.. The 510(k) number is K771176.

When did GOTHIC ARCH TRACING receive FDA 510(k) clearance?

GOTHIC ARCH TRACING received FDA 510(k) clearance on 1977-08-16, under 510(k) number K771176.

Who is the listed applicant for GOTHIC ARCH TRACING?

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 GOTHIC ARCH TRACING?

The FDA product code for GOTHIC ARCH TRACING is KZO.

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Related Devices (Code: KZO)

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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