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FDA 510(k)

ORALSAFE

K-Number: K923469 · 1992-10-05

ApplicantOralsafe, Inc.
Decision Date1992-10-05
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORALSAFE is the device name listed in this FDA 510(k) record. The listed applicant is Oralsafe, Inc.. It received FDA 510(k) clearance on 1992-10-05 under 510(k) number K923469. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORALSAFE?

ORALSAFE is a medical device that received FDA 510(k) clearance on 1992-10-05. The listed applicant is Oralsafe, Inc.. The 510(k) number is K923469.

When did ORALSAFE receive FDA 510(k) clearance?

ORALSAFE received FDA 510(k) clearance on 1992-10-05, under 510(k) number K923469.

Who is the listed applicant for ORALSAFE?

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

What is the FDA product code for ORALSAFE?

The FDA product code for ORALSAFE is EFB.

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Related Devices (Code: EFB)

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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