Oral-B Nighttime Dental Guard

GUDID D132MG0010

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

Oralabs, LLC

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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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

Devices Manufactured by Oralabs, LLC

• 00050428446102 - CVS Dry Mouth Spray: 2024-02-06 Artificial Saliva - Dry Mouth Spray
• 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 -