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FDA 510(k)

FASTDAM

K-Number: K972775 · 1998-02-27

ApplicantInterdent, Inc.
Decision Date1998-02-27
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FASTDAM is the device name listed in this FDA 510(k) record. The listed applicant is Interdent, Inc.. It received FDA 510(k) clearance on 1998-02-27 under 510(k) number K972775. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTDAM?

FASTDAM is a medical device that received FDA 510(k) clearance on 1998-02-27. The listed applicant is Interdent, Inc.. The 510(k) number is K972775.

When did FASTDAM receive FDA 510(k) clearance?

FASTDAM received FDA 510(k) clearance on 1998-02-27, under 510(k) number K972775.

Who is the listed applicant for FASTDAM?

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

What is the FDA product code for FASTDAM?

The FDA product code for FASTDAM is EIE.

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Other records listing Interdent, Inc. as applicant

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.

K823457NON-PRESSURE AUTOCLAVE FOR STERILIZATION

Related Devices (Code: EIE)

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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