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FDA 510(k)

LIME-LITE II

K-Number: K113711 · 2012-03-05

ApplicantPulpdent Corporation
Decision Date2012-03-05
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LIME-LITE II is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2012-03-05 under 510(k) number K113711. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIME-LITE II?

LIME-LITE II is a medical device that received FDA 510(k) clearance on 2012-03-05. The listed applicant is Pulpdent Corporation. The 510(k) number is K113711.

When did LIME-LITE II receive FDA 510(k) clearance?

LIME-LITE II received FDA 510(k) clearance on 2012-03-05, under 510(k) number K113711.

Who is the listed applicant for LIME-LITE II?

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

What is the FDA product code for LIME-LITE II?

The FDA product code for LIME-LITE II is EJK.

Other records listing Pulpdent Corporation as applicant

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Related Devices (Code: EJK)

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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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