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FDA 510(k)

SPECTRA FLUORESCENCE CARIES DETECTION DEVICE

K-Number: K090169 · 2009-08-18

ApplicantAir Techniques, Inc.
Decision Date2009-08-18
Product CodeNBL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPECTRA FLUORESCENCE CARIES DETECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Air Techniques, Inc.. It received FDA 510(k) clearance on 2009-08-18 under 510(k) number K090169. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRA FLUORESCENCE CARIES DETECTION DEVICE?

SPECTRA FLUORESCENCE CARIES DETECTION DEVICE is a medical device that received FDA 510(k) clearance on 2009-08-18. The listed applicant is Air Techniques, Inc.. The 510(k) number is K090169.

When did SPECTRA FLUORESCENCE CARIES DETECTION DEVICE receive FDA 510(k) clearance?

SPECTRA FLUORESCENCE CARIES DETECTION DEVICE received FDA 510(k) clearance on 2009-08-18, under 510(k) number K090169.

Who is the listed applicant for SPECTRA FLUORESCENCE CARIES DETECTION DEVICE?

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

What is the FDA product code for SPECTRA FLUORESCENCE CARIES DETECTION DEVICE?

The FDA product code for SPECTRA FLUORESCENCE CARIES DETECTION DEVICE is NBL.

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Other records listing Air Techniques, Inc. as applicant

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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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