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
00815967026112RodinPac-Dent, Inc.MQC2026-05-20
00190730084583Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
00190730084590Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
H66842000141KeyPrintKeystone IndustriesMQC2024-09-26
H66841101411KeyPrintKeystone IndustriesMQC2023-09-25
H66842201511KeyPrintKeystone IndustriesMQC2023-09-25
EPRCD1001501printodent GR-19.1 OApro3dure medical GmbHMQC2023-08-29
EPRCD1001504printodent GR-19.1 OA I MSIpro3dure medical GmbHMQC2023-08-29
D745701164RSN00070Glidewell TuffSplint™ Appliance ResinPrismatik Dentalcraft, IncMQC2023-04-11
00810002220241The Luco Hybrid OSA ApplianceJOHN'S DENTAL LABORATORY INCMQC2023-03-28
00810002220241The Luco Hybrid OSA ApplianceJOHN'S DENTAL LABORATORY INCOCO2023-03-28
H66842000111KeyPrintKeystone IndustriesMQC2023-02-20
H66842001611KeyPrintKeystone IndustriesMQC2023-02-20
H66842200111KeyPrintKeystone IndustriesMQC2023-02-20
H66842201141HeyGearsKeystone IndustriesMQC2023-02-20
H66842201611KeyPrintKeystone IndustriesMQC2023-02-20
H66850524011Nexa3DKeystone IndustriesMQC2023-02-20
H66852233011Nexa3DKeystone IndustriesMQC2023-02-20
H668D6400231PearsonKeystone IndustriesMQC2023-02-20
H668D6400241PearsonKeystone IndustriesMQC2023-02-20
H668D6400271PearsonKeystone IndustriesMQC2023-02-20
H668210041American DentalKeystone IndustriesMQC2022-11-30
H668210051American DentalKeystone IndustriesMQC2022-11-30
H668210061American DentalKeystone IndustriesMQC2022-11-30
H66870001901ProformKeystone IndustriesMQC2022-11-30
H6687000190R11ProformKeystone IndustriesMQC2022-11-30
H6687000190R21ProformKeystone IndustriesMQC2022-11-30
H66870001911ProformKeystone IndustriesMQC2022-11-30
H6687000191R11ProformKeystone IndustriesMQC2022-11-30
H6687000191R21ProformKeystone IndustriesMQC2022-11-30