Silent Nite Sleep Appliance with Glidewell Hinge SNGLHGXPHL

GUDID D745SNGLHGXPHL0

Silent Nite Sleep Appliance with Glidewell Hinge Original Part Lower

James R. Glidewell, Dental Ceramics, Inc.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: D745SNGLHGXPHL0
• NIH Device Record Key: 08789178-6607-4850-bfed-ce5cac34acae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silent Nite Sleep Appliance with Glidewell Hinge
• Version Model Number: SNGLHGXPHL
• Catalog Number: SNGLHGXPHL
• Company DUNS: 021228671
• Company Name: James R. Glidewell, Dental Ceramics, 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

Customer Support Contacts

• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745SNGLHGXPHL0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210694

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: 2022-07-08
• Device Publish Date: 2022-06-30

On-Brand Devices [Silent Nite Sleep Appliance with Glidewell Hinge]

• D745SNGLHGXPHU0: Silent Nite Sleep Appliance with Glidewell Hinge Original Part Upper
• D745SNGLHGXPHL0: Silent Nite Sleep Appliance with Glidewell Hinge Original Part Lower
• D745SNGLHGXP0: Silent Nite Sleep Appliance with Glidewell Hinge Original Parts
• D745SNGLHGHU0: Silent Nite Sleep Appliance with Glidewell Hinge Half Upper
• D745SNGLHGHL0: Silent Nite Sleep Appliance with Glidewell Hinge Half Lower
• D745SNGLHGADJ0: Silent Nite Sleep Appliance with Glidewell Hinge Adjust
• D745SNGLHG0: Silent Nite Sleep Appliance with Glidewell Hinge