Silent Nite 3D Sleep Appliance MA-PC-SD-LA

GUDID D745MAPCSDLA0

Silent Nite 3D Sleep Appliance Lower Tray

Prismatik Dentalcraft, Inc

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: D745MAPCSDLA0
• NIH Device Record Key: c73a2e89-54e6-4f8f-827d-88379d65ff59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silent Nite 3D Sleep Appliance
• Version Model Number: MA-PC-SD-LA
• Catalog Number: MA-PC-SD-LA
• Company DUNS: 022761689
• Company Name: Prismatik Dentalcraft, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745MAPCSDLA0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211069

FDA Product Code

• LRK: Device, anti-snoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-23
• Device Publish Date: 2024-04-15

On-Brand Devices [Silent Nite 3D Sleep Appliance]

• D745MAPCSDUA0: Silent Nite 3D Sleep Appliance Upper Tray
• D745MAPCSDOP0: Silent Nite 3D Sleep Appliance
• D745MAPCSDLA0: Silent Nite 3D Sleep Appliance Lower Tray