FDA.reportPublic FDA data

SmartGuard

Primary DI
00866330000208
Brand
SmartGuard
Company
Smartguard Rx, Inc.
Model
SGDG6
Device description
Dental mouth guard for clenching and grinding teeth (bruxism)
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123161000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123161000SMARTGUARD NIGHT GUARD, SMARTGUARD ORIGINAL, SMARTGUARD NIGHT GUARD ORIGINAL, SMARTGUARD ELITESmartguard, Inc.2013-03-14MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10866330000205PackageGS13In Commercial Distribution
20866330000202PackageGS14In Commercial Distribution
30866330000209PackageGS112In Commercial Distribution
00866330000208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086633000020510866330000205
2086633000020220866330000202
3086633000020930866330000209
00866330000208008663300002088663300002080866330000208

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
1-855-576-2785brian@smartguardrx.com

Regulatory Flags#

DUNS number
079556398
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866330000260SmartGuardSGASD2021-11-05
10866330000205SmartGuardSGDG62020-09-24

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
05060687651877ClenchNoMore1987 MEDIA LIMITEDOBR2026-07-17
05060687651891ClenchNoMore1987 MEDIA LIMITEDOBR2026-07-17
05060687651907ClenchNoMore1987 MEDIA LIMITEDOBR2026-07-17
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