Oral-B Nighttime Dental Guard

GUDID D132MG0010

Oral-B Nighttime Dental Guard - For Nighttime Teeth Grinding Protection -

Oralabs, LLC

Mouthguard, reusable

• Primary Device ID: D132MG0010
• NIH Device Record Key: c8e9bc32-b499-4da6-bee1-89d11c7788fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oral-B Nighttime Dental Guard
• Version Model Number: 1
• Company DUNS: 801824756
• Company Name: Oralabs, LLC
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-600-2861
• Email: xx@xx.xx
• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
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• Phone: 1-800-600-2861
• Email: xx@xx.xx
• Phone: 1-800-600-2861
• Email: xx@xx.xx
• Phone: 1-800-600-2861
• Email: xx@xx.xx
• Phone: 1-800-600-2861
• Email: xx@xx.xx
• Phone: 1-800-600-2861
• Email: xx@xx.xx
• Phone: 1-800-600-2861
• Email: xx@xx.xx
• Phone: 1-800-600-2861
• Email: xx@xx.xx
• Phone: 1-800-600-2861
• Email: xx@xx.xx
• Phone: 1-800-600-2861
• Email: xx@xx.xx

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00728947000210 [Secondary]
HIBCC	D132MG0010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113326

FDA Product Code

• OMR: Vessel Guard Or Cover

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: 2023-08-14
• Device Publish Date: 2023-08-04

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• 00708820384446 - Meijer: 2024-02-06 Saliva, Artificial
• D132DMS0010 - CVS Dry Mouth Spray: 2023-08-22 Artificial Saliva - Dry Mouth Spray
• D132MG0010 - Oral-B Nighttime Dental Guard: 2023-08-14Oral-B Nighttime Dental Guard - For Nighttime Teeth Grinding Protection -
• D132MG0010 - Oral-B Nighttime Dental Guard: 2023-08-14 Oral-B Nighttime Dental Guard - For Nighttime Teeth Grinding Protection -