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FDA 510(k)

BIO-SCREEN

K-Number: K082668 · 2009-01-23

ApplicantAddent, Inc.
Decision Date2009-01-23
Product CodeNXV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIO-SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Addent, Inc.. It received FDA 510(k) clearance on 2009-01-23 under 510(k) number K082668. The device is classified under product code NXV. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-SCREEN?

BIO-SCREEN is a medical device that received FDA 510(k) clearance on 2009-01-23. The listed applicant is Addent, Inc.. The 510(k) number is K082668.

When did BIO-SCREEN receive FDA 510(k) clearance?

BIO-SCREEN received FDA 510(k) clearance on 2009-01-23, under 510(k) number K082668.

Who is the listed applicant for BIO-SCREEN?

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

What is the FDA product code for BIO-SCREEN?

The FDA product code for BIO-SCREEN is NXV.

Related Clinical Trials

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Other records listing Addent, 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.

K182017Compex HDK121282MICROLUX/DL MICROLUX/BLU BIO/SCREENK072309MICROLUX/BLUK062961MICROLUX TRANSILLUMINATORK061395CALSET COMPOSITE HEATERK041614MICROLUX DL

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Related Devices (Code: NXV)

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.

K123169ORALIDForward Science, LLCK121282MICROLUX/DL MICROLUX/BLU BIO/SCREENAddent, Inc.K102083VELSCOPE VXLed Dental, Inc.K101140DENTLIGHT ORAL EXAM LIGHT KITDentlight, Inc.K090135TRIMIRA IDENTAFI 3000Remicalm, LLCK082603TRIMIRA OCS 3000Remicalm, LLC

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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