Oral-B Nighttime Dental Guard

FDA UDI

Class II (US FDA UDI)

by Oralabs, Inc.

Identity

Trade Name: Oral-B Nighttime Dental Guard FDA UDI
Generic Name: Mouthguard, reusable FDA UDI
Device Name: Oral-B Nighttime Dental Guard - For Nighttime Teeth Grinding Protection - FDA UDI
Model / Reference: 1 FDA UDI
Description: Oral-B Nighttime Dental Guard - For Nighttime Teeth Grinding Protection - FDA UDI

Identifiers

Primary DI / UDI-DI: D132MG0010 FDA UDI
510(k) Number: K113326 FDA UDI
FDA Product Code: OMR FDA UDI
GMDN Term: Mouthguard, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.3470 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Mouthguard, reusable

Oral-B Nighttime Dental Guard by Oralabs, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Mouthguard, reusable.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Oralabs, Inc.

Sources (1)

FDA UDI c8e9bc32-b499-4da6-bee1-89d11c7788fb 36 fields · synced May 30, 2026