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FDA 510(k)

AVANTE LED CURING UNIT, MODEL N44

K-Number: K052349 · 2005-10-21

ApplicantPentron Clinical Technologies
Decision Date2005-10-21
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AVANTE LED CURING UNIT, MODEL N44 is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Clinical Technologies. It received FDA 510(k) clearance on 2005-10-21 under 510(k) number K052349. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVANTE LED CURING UNIT, MODEL N44?

AVANTE LED CURING UNIT, MODEL N44 is a medical device that received FDA 510(k) clearance on 2005-10-21. The listed applicant is Pentron Clinical Technologies. The 510(k) number is K052349.

When did AVANTE LED CURING UNIT, MODEL N44 receive FDA 510(k) clearance?

AVANTE LED CURING UNIT, MODEL N44 received FDA 510(k) clearance on 2005-10-21, under 510(k) number K052349.

Who is the listed applicant for AVANTE LED CURING UNIT, MODEL N44?

The FDA 510(k) record lists Pentron Clinical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVANTE LED CURING UNIT, MODEL N44?

The FDA product code for AVANTE LED CURING UNIT, MODEL N44 is EBZ.

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Related Devices (Code: EBZ)

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

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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