FDA.reportPublic FDA data

BruxArmor

Primary DI
00810180631006
Brand
BruxArmor
Company
Dental Choice Holdings LLC
Model
BL2
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183315000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183315000CustMBite Dental GuardDental Choice Holdings, LLC2019-08-23OBR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810180631006PrimaryGS10
00810180633024Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810180631006008101806310068101806310060810180631006
00810180633024008101806330248101806330240810180633024

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.

Regulatory Flags#

DUNS number
116792139
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810036601245RestwellCL2026-10-23
00810036601801Wake RightCL2026-10-23
00810036604185Dental DefenseCL2026-10-23
00810036604192Dental DefenseBL2026-10-23
00810036604208Dental DefenseAQ2026-10-23
00810036604246Sleep RoyaltyPRP2026-10-23
00810036604253Sleep RoyaltyCL2026-10-23
00810036604284Rodeo DentalCLY2026-10-24
00810036604291Rodeo DentalBL2026-10-24
00810036604307Rodeo DentalPINY2026-10-24
00810036604314Rodeo DentalCL2026-10-24
00810036604758La Mejor SonrisaOR2026-10-23
00810036604901Rodeo DentalBLY2026-10-24
00810036604932Rodeo DentalPIN2026-10-24
00810036604970La Mejor SonrisaPIN2026-10-23
00810036604987La Mejor SonrisaYE2026-10-23
00810036604994La Mejor SonrisaBL2026-10-23
00810036605007La Mejor SonrisaCLRET2026-10-23
00810036606714BruxArmorBL012026-10-23
00810036606783America's ToothfairyCL2026-10-24

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