FDA.reportPublic FDA data

Oral-B Nighttime Dental Guard

Primary DI
D132MG0010
Brand
Oral-B Nighttime Dental Guard
Company
Oralabs, LLC
Model
1
Device description
Oral-B Nighttime Dental Guard - For Nighttime Teeth Grinding Protection -
Published
2023-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMRVessel Guard Or Cover

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMRVessel Guard Or CoverCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113326000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113326000ORAL B PLUS OUTLAST NIGHT TIME DENTAL GUARDOralabs, Inc.2012-06-27OBR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D132MG0010PrimaryHIBCC0
00728947000210SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00728947000210007289470002107289470002100728947000210

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-600-2861xx@xx.xx

Regulatory Flags#

DUNS number
801824756
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D132DMS0020CVS Dry Mouth Spray0022024-01-29
D132DMS0030Meijer0012024-01-29
00050428446102CVS Dry Mouth Spray0022024-01-29
00708820384446Meijer0012024-01-29
D132DMS0010CVS Dry Mouth Spray0012023-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705034753799SCOUTSYNTHES (U.S.A.) LPOMR2015-09-14
10705034753805SCOUTSYNTHES (U.S.A.) LPOMR2015-09-14
H98108650101S0SCOUTSYNTHES (U.S.A.) LPOMR2015-09-14
H98108650102S0SCOUTSYNTHES (U.S.A.) LPOMR2015-09-14