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FDA 510(k)

Silent Nite sl

K-Number: K183270 · 2019-07-17

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2019-07-17
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Silent Nite sl is the device name listed in this FDA 510(k) record. The listed applicant is Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2019-07-17 under 510(k) number K183270. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Silent Nite sl?

Silent Nite sl is a medical device that received FDA 510(k) clearance on 2019-07-17. The listed applicant is Prismatik Dentalcraft, Inc.. The 510(k) number is K183270.

When did Silent Nite sl receive FDA 510(k) clearance?

Silent Nite sl received FDA 510(k) clearance on 2019-07-17, under 510(k) number K183270.

Who is the listed applicant for Silent Nite sl?

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

What is the FDA product code for Silent Nite sl?

The FDA product code for Silent Nite sl is LRK.

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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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