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FDA 510(k)

DENTLIGHT ORAL EXAM LIGHT KIT

K-Number: K101140 · 2010-07-15

ApplicantDentlight, Inc.
Decision Date2010-07-15
Product CodeNXV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTLIGHT ORAL EXAM LIGHT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dentlight, Inc.. It received FDA 510(k) clearance on 2010-07-15 under 510(k) number K101140. 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 DENTLIGHT ORAL EXAM LIGHT KIT?

DENTLIGHT ORAL EXAM LIGHT KIT is a medical device that received FDA 510(k) clearance on 2010-07-15. The listed applicant is Dentlight, Inc.. The 510(k) number is K101140.

When did DENTLIGHT ORAL EXAM LIGHT KIT receive FDA 510(k) clearance?

DENTLIGHT ORAL EXAM LIGHT KIT received FDA 510(k) clearance on 2010-07-15, under 510(k) number K101140.

Who is the listed applicant for DENTLIGHT ORAL EXAM LIGHT KIT?

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

What is the FDA product code for DENTLIGHT ORAL EXAM LIGHT KIT?

The FDA product code for DENTLIGHT ORAL EXAM LIGHT KIT is NXV.

Related Clinical Trials

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Other records listing Dentlight, 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.

K201387Ultrafast, Ultrafast Plus, Ultrafast LiteK180065FUSION Plus Curing LightK052593FUSION CURING LIGHT

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.K090135TRIMIRA IDENTAFI 3000Remicalm, LLCK082668BIO-SCREENAddent, Inc.K082603TRIMIRA 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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