FDA.reportPublic FDA data

BRUX NIGHT GUARD

Primary DI
00860003090411
Brand
BRUX NIGHT GUARD
Company
LATE NIGHT CONCEPTS, INC
Model
BR-102
Catalog number
BNG
Device description
Custom-fit thermoplastic dental night guard for protection against teeth grinding (bruxism) during sleep. Single-user, multi-use, boil-and-bite molded for individual fit. Over-the-counter.
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181361000Brux Night GuardBrux Night Guard2019-04-11MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003090411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003090411008600030904118600030904110860003090411

GMDN Terms#

Term, Definition table
TermDefinition
Removable dental occlusal splint, customizableA device intended for home-use intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is removable by the patient (e.g., during meals), and is typically made of plastic materials and can be softened, typically in hot water, and moulded over the teeth by the user to provide an anatomical fit (customizable). This is a reusable device.

Regulatory Flags#

DUNS number
080973935
Device count
1
Lot or batch
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D9821716301LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716311LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716321LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716331LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716341LuxaPrint Ortho Plus NX 385 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716351LuxaPrint Ortho Plus NX 405 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716361LuxaPrint Ortho Plus NX 405 nmDMG Digital Enterprises SEMQC2026-07-21
D9821716371LuxaPrint Ortho Plus NX 405 nmDMG Digital Enterprises SEMQC2026-07-21
04260670160510dentona flexisplintdentona AGMQC2026-06-23
04260670160527dentona flexisplintdentona AGMQC2026-06-23
04260670160534dentona flexisplintdentona AGMQC2026-06-23
04260670160541dentona flexisplintdentona AGMQC2026-06-23
04260670160558dentona flexisplintdentona AGMQC2026-06-23
04260670160572dentona flexisplintdentona AGMQC2026-06-23
04260670160589dentona flexisplintdentona AGMQC2026-06-23
04260670160596dentona vivatempdentona AGMQC2026-06-23
04260670160602dentona vivatempdentona AGMQC2026-06-23
04260670160619dentona vivatempdentona AGMQC2026-06-23
04260670160626dentona vivatempdentona AGMQC2026-06-23
04260670160633dentona vivatempdentona AGMQC2026-06-23
04260670160640dentona vivatempdentona AGMQC2026-06-23
04260670160657dentona vivatempdentona AGMQC2026-06-23
04260670160688optimill memosplintdentona AGMQC2026-06-23
04260670160695optimill memosplintdentona AGMQC2026-06-23
04260670160701optimill memosplintdentona AGMQC2026-06-23
04260670160718optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160725optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160732optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160749optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160756optimill memosplint Version Sdentona AGMQC2026-06-23