FDA.reportPublic FDA data

Walgreens

Primary DI
00311917046877
Brand
Walgreens
Company
WALGREEN CO.
Model
630109
Catalog number
SQN5494SB1
Device description
Walgreens Dental GuardFor Nighttime Teeth Grinding (Bruxism)2 Dental Guards, 1 Storage Case, 1 Fitting Tray
Published
2024-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OBRMouthguard, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBRMouthguard, Over-The-CounterUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10311917046874PackageGS16In Commercial Distribution
00311917046877PrimaryGS10
40311917046875Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1031191704687410311917046874
00311917046877003119170468773119170468770311917046877
4031191704687540311917046875

GMDN Terms#

Term, Definition table
TermDefinition
Mouthguard, reusableA prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during endoscopic diagnostic procedures, contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-800-925-4733consumerrelations.pq@walgreens.com

Regulatory Flags#

DUNS number
008965063
Device count
2

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00311917034218Walgreens7654302023-07-11
00311917034249Walgreens7654262023-07-11
00311917077932Walgreens7394332026-10-14
00311917090498Walgreens4172342026-10-12
00311917088556Walgreens3119170885562026-09-30
00311917086521Walgreens1439332026-09-28
00311917156064WALGREENS2576322020-07-22
00311917080062Walgreens7610162026-08-26
00311917086569Walgreens1666772026-08-21
00311917086590Walgreens1666372026-08-21
00311917122045Walgreens5052882023-03-09
00311917158952Walgreens276743WRX2767432020-07-14
00311917014876Walgreens6772599288502016-12-20
00311917048130Walgreens6548789288562016-12-20
00311917014920Walgreens6772579288522016-12-20
00311917025360Walgreens6545679288572016-12-20
00311917048154Walgreens6548829288582016-12-20
00311917085685Walgreens7208802026-05-08
00311917085692Walgreens7208932026-05-08
00311917085739Walgreens7208942026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810036604284Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604291Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604307Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604314Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604901Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604932Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036606783America's ToothfairyDental Choice Holdings LLCOBR2026-10-24
00810036607353America's ToothfairyDental Choice Holdings LLCOBR2026-10-24
00810036601245RestwellDental Choice Holdings LLCOBR2026-10-23
00810036601801Wake RightDental Choice Holdings LLCOBR2026-10-23
00810036604185Dental DefenseDental Choice Holdings LLCOBR2026-10-23
00810036604192Dental DefenseDental Choice Holdings LLCOBR2026-10-23
00810036604208Dental DefenseDental Choice Holdings LLCOBR2026-10-23
00810036604246Sleep RoyaltyDental Choice Holdings LLCOBR2026-10-23
00810036604253Sleep RoyaltyDental Choice Holdings LLCOBR2026-10-23
00810036604758La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036604970La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036604987La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036604994La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036605007La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036606714BruxArmorDental Choice Holdings LLCOBR2026-10-23
00810036606813ResolveDental Choice Holdings LLCOBR2026-10-23
00810036606820ResolveDental Choice Holdings LLCOBR2026-10-23
00810036606837ResolveDental Choice Holdings LLCOBR2026-10-23
00810036607520KloudDental Choice Holdings LLCOBR2026-10-23
00810036607537KloudDental Choice Holdings LLCOBR2026-10-23
00810036607544Rest In PeaceDental Choice Holdings LLCOBR2026-10-23
00810036607551Rest In PeaceDental Choice Holdings LLCOBR2026-10-23
00810036607599Sleep PeachyDental Choice Holdings LLCOBR2026-10-23
00810036607605Sleep PeachyDental Choice Holdings LLCOBR2026-10-23