FDA.reportPublic FDA data

Myobrace®

Primary DI
19330944000056
Brand
Myobrace®
Company
MYOFUNCTIONAL RESEARCH CORPORATION PTY. LIMITED
Model
A2
Catalog number
MA2Lpp
Published
2025-05-16
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
19330944000056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1933094400005619330944000056

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.

Sterilization Methods#

Method table
Method

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
19330944002326Myoretainr®RAMRAMc2025-07-04
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
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
08054154160044EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154160068EQULIBRATORE 1.3EPTAMED SRLKMY2026-08-27
08054154160082EQUILIBRATORE 1.4EPTAMED SRLKMY2026-08-27
08054154160242EQUILIBRATORE C4PEPTAMED SRLKMY2026-08-27
08054154161041EQUILIBRATORE 1.0EPTAMED SRLKMY2026-08-27
08054154161058EQUILIBRATORE 1.0EPTAMED SRLKMY2026-08-27
08054154161065EQUILIBRATORE 1.05EPTAMED SRLKMY2026-08-27
08054154161072EQUILIBRATORE 1.05EPTAMED SRLKMY2026-08-27
08054154161096EQUILIBRATORE 1.1EPTAMED SRLKMY2026-08-27
08054154161102EQUILIBRATORE 1.1EPTAMED SRLKMY2026-08-27
08054154161218EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154161225EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154161232EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154161249EQUILIBRATORE 1.2-SEPTAMED SRLKMY2026-08-27
08054154161256EQUILIBRATORE 1.2-SEPTAMED SRLKMY2026-08-27
08054154161263EQUILIBRATORE 1.2-SEPTAMED SRLKMY2026-08-27
08054154161270EQUILIBRATORE 1.2-SEPTAMED SRLKMY2026-08-27
08054154161294EQUILIBRATORE 1.3EPTAMED SRLKMY2026-08-27
08054154161300EQUILIBRATORE 1.3EPTAMED SRLKMY2026-08-27
08054154161317EQUILIBRATORE 1.3-SEPTAMED SRLKMY2026-08-27
08054154161324EQUILIBRATORE 1.3-SEPTAMED SRLKMY2026-08-27
08054154161331EQUILIBRATORE 1.3-SEPTAMED SRLKMY2026-08-27
08054154161348EQUILIBRATORE 1.3-SEPTAMED SRLKMY2026-08-27
08054154161355EQUILIBRATORE 1.4EPTAMED SRLKMY2026-08-27
08054154161362EQUILIBRATORE 1.4EPTAMED SRLKMY2026-08-27
08054154161379EQUILIBRATORE 1.4-SEPTAMED SRLKMY2026-08-27
08054154161386EQUILIBRATORE 1.4-SEPTAMED SRLKMY2026-08-27
08054154161591EQUILIBRATORE C2EPTAMED SRLKMY2026-08-27
08054154161607EQUILIBRATORE C2EPTAMED SRLKMY2026-08-27
08054154161614EQUILIBRATORE C2EPTAMED SRLKMY2026-08-27