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FDA 510(k)

ORASCOPE

K-Number: K991011 · 1999-06-23

ApplicantFiberdent Corp.
Decision Date1999-06-23
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORASCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Fiberdent Corp.. It received FDA 510(k) clearance on 1999-06-23 under 510(k) number K991011. 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 ORASCOPE?

ORASCOPE is a medical device that received FDA 510(k) clearance on 1999-06-23. The listed applicant is Fiberdent Corp.. The 510(k) number is K991011.

When did ORASCOPE receive FDA 510(k) clearance?

ORASCOPE received FDA 510(k) clearance on 1999-06-23, under 510(k) number K991011.

Who is the listed applicant for ORASCOPE?

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

What is the FDA product code for ORASCOPE?

The FDA product code for ORASCOPE is EIA.

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Related Devices (Code: EIA)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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