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FDA 510(k)

SAPPHIRE O/E ORAL EXAMINATION SYSTEM

K-Number: K073483 · 2008-04-03

ApplicantDen-Mat Holdings, LLC
Decision Date2008-04-03
Product CodeNXV
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAPPHIRE O/E ORAL EXAMINATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Holdings, LLC. It received FDA 510(k) clearance on 2008-04-03 under 510(k) number K073483. 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 SAPPHIRE O/E ORAL EXAMINATION SYSTEM?

SAPPHIRE O/E ORAL EXAMINATION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-03. The listed applicant is Den-Mat Holdings, LLC. The 510(k) number is K073483.

When did SAPPHIRE O/E ORAL EXAMINATION SYSTEM receive FDA 510(k) clearance?

SAPPHIRE O/E ORAL EXAMINATION SYSTEM received FDA 510(k) clearance on 2008-04-03, under 510(k) number K073483.

Who is the listed applicant for SAPPHIRE O/E ORAL EXAMINATION SYSTEM?

The FDA 510(k) record lists Den-Mat Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAPPHIRE O/E ORAL EXAMINATION SYSTEM?

The FDA product code for SAPPHIRE O/E ORAL EXAMINATION SYSTEM is NXV.

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Other records listing Den-Mat Holdings, LLC 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.

K262252MPa Max adhesiveK242097DenMat Bulk Fill CompositeK162967nuance UNIVERSALK110079SPPHINE PLUS STM 3W DIODE LASERK103667SAPPHIRE ST PORTABLE DIODE LASERK081287SAPPHIRE PLASMA ARC DENTAL CURING LIGHT

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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, LLCK082668BIO-SCREENAddent, Inc.

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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