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FDA 510(k)

BUILD-IT LIGHT CURE

K-Number: K091512 · 2009-10-30

ApplicantPentron Clinical Technologies
Decision Date2009-10-30
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BUILD-IT LIGHT CURE 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 2009-10-30 under 510(k) number K091512. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BUILD-IT LIGHT CURE?

BUILD-IT LIGHT CURE is a medical device that received FDA 510(k) clearance on 2009-10-30. The listed applicant is Pentron Clinical Technologies. The 510(k) number is K091512.

When did BUILD-IT LIGHT CURE receive FDA 510(k) clearance?

BUILD-IT LIGHT CURE received FDA 510(k) clearance on 2009-10-30, under 510(k) number K091512.

Who is the listed applicant for BUILD-IT LIGHT CURE?

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 BUILD-IT LIGHT CURE?

The FDA product code for BUILD-IT LIGHT CURE is EBF.

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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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