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FDA 510(k)

Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)

K-Number: K233434 · 2023-11-14

ApplicantPrismatik Dentalcraft, Inc.
Decision Date2023-11-14
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) is a medical device manufactured by Prismatik Dentalcraft, Inc.. It received FDA 510(k) clearance on 2023-11-14 under approval number K233434. 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® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)?

Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) is a medical device that received FDA 510(k) clearance on 2023-11-14. It is manufactured by Prismatik Dentalcraft, Inc.. The 510(k) number is K233434.

When was Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) approved by the FDA?

Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) received FDA 510(k) clearance on 2023-11-14, under approval number K233434.

What company makes Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)?

Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) is manufactured by Prismatik Dentalcraft, Inc..

What is the FDA product code for Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)?

The FDA product code for Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) is LRK.

Related Clinical Trials

NCT04092660 Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea. RECRUITING NCT07359638 Impact of a Mandibular Oral Repositioning Device on Sleep Quality, Heart Rate Variability, & SpO2 RECRUITING

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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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