FDA.reportPublic FDA data

Myoretainr®

Primary DI
19330944002326
Brand
Myoretainr®
Company
MYOFUNCTIONAL RESEARCH CORPORATION PTY. LIMITED
Model
RA
Catalog number
MRAMc
Published
2025-07-04
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
KMYPOSITIONER, TOOTH, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19330944002326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1933094400232619330944002326

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

Regulatory Flags#

DUNS number
742030310
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19330944002333Myoretainr®RAMRALc2025-08-22
19330944002319Myobrace®AA3MAA3Lc2025-07-08
19330944002241Myobrace®AA3MAA3Mc2025-07-04
19330944000438Myobrace®K1MK1Sb2025-05-21
19330944000506Myobrace®K2MK2Mc2025-05-21
19330944001008Myobrace®i-3Mi3Sc2025-05-21
19330944001084Myobrace®i-3NMi3nSy2025-05-21
19330944001657Myotalea®TLP-HMTTLPhc2025-05-21
19330944001732The TMJ System™TMJ-MBVTMJ-MBV2025-05-21
19330944001763The Trainer System™T4A Phase 1T4A1Lc2025-05-21
19330944000056Myobrace®A2MA2Lpp2025-05-16
19330944000292Myobrace®J2MJ2Mp2025-05-16
19330944000797Myobrace®T3MT3-12025-05-16
19330944000889Myobrace®T3NMT3n-32025-05-16
19330944001510Myotalea®LSTLSTp2025-05-16
19330944001534Myotalea®LTMTLTb2025-05-16
19330944001558Myotalea®LTMTLTp2025-05-16
19330944001572Myotalea®MyochewMTCBc2025-05-16
19330944001596Myotalea®TLJMTTLJLc2025-05-16
19330944001695The TMJ System™Bruxogard SoftBruxS2025-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800142101007Tera TainerGraphy Inc.KMY2026-05-14
H66842000141KeyPrintKeystone IndustriesKMY2024-09-26
H66841101411KeyPrintKeystone IndustriesKMY2023-09-25
H66842201511KeyPrintKeystone IndustriesKMY2023-09-25
08719425509549Vertex-Dental BVVertex-Dental B.V.KMY2023-06-20
08719425509556NextDentVertex-Dental B.V.KMY2023-06-15
H66842000111KeyPrintKeystone IndustriesKMY2023-02-20
H66842001611KeyPrintKeystone IndustriesKMY2023-02-20
H66842200111KeyPrintKeystone IndustriesKMY2023-02-20
H66842201141HeyGearsKeystone IndustriesKMY2023-02-20
EPRCD1001609PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001610PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001611PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
H668210241American DentalKeystone IndustriesKMY2022-11-30
H668210251American DentalKeystone IndustriesKMY2022-11-30
H668210261American DentalKeystone IndustriesKMY2022-11-30
H668210271American DentalKeystone IndustriesKMY2022-11-30
H668210341American DentalKeystone IndustriesKMY2022-11-30
EPRCD1001703PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRCD1001704PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRC66077916dima Print Splint clear pro3dure medical GmbHKMY2021-11-25
EPRCD1000800PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1000801PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1001491PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001492PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001493PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001701PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
EPRCD1001702PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
ERKO5142052ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5142072ErkolenErkodent Erich Kopp GmbHKMY2021-09-21