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FDA 510(k)

SPECTACLE FRAME, OP-TITE

K-Number: K772368 · 1978-01-30

ApplicantDentsply Intl.
Decision Date1978-01-30
Product CodeHQZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SPECTACLE FRAME, OP-TITE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1978-01-30 under 510(k) number K772368. The device is classified under product code HQZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTACLE FRAME, OP-TITE?

SPECTACLE FRAME, OP-TITE is a medical device that received FDA 510(k) clearance on 1978-01-30. The listed applicant is Dentsply Intl.. The 510(k) number is K772368.

When did SPECTACLE FRAME, OP-TITE receive FDA 510(k) clearance?

SPECTACLE FRAME, OP-TITE received FDA 510(k) clearance on 1978-01-30, under 510(k) number K772368.

Who is the listed applicant for SPECTACLE FRAME, OP-TITE?

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 SPECTACLE FRAME, OP-TITE?

The FDA product code for SPECTACLE FRAME, OP-TITE is HQZ.

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Related Devices (Code: HQZ)

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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