FDA.reportPublic FDA data

Myoaligner®

Primary DI
00860015852106
Brand
Myoaligner®
Company
MYOHEALTH TECHNOLOGIES, INC
Model
MYO-001
Device description
Segmented Anatomical Intraoral Device
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription
OCOMouthguard, Migraine/Tension Headache

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU
OCOMouthguard, Migraine/Tension HeadacheUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230548000Myoaligner ApplianceMyohealth Technologies, LLC2024-02-02MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015852106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015852106008600158521068600158521060860015852106

GMDN Terms#

Term, Definition table
TermDefinition
Removable dental occlusal splint, custom-madeA rigid or flexible custom-made device 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 synthetic polymer materials and manufactured to meet the needs of an individual patient. This is a reusable device.

Regulatory Flags#

DUNS number
018000231
Device count
1
Manufacturing date on label
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