FDA.reportPublic FDA data

The TMJ System™

Primary DI
19330944001695
Brand
The TMJ System™
Company
MYOFUNCTIONAL RESEARCH CORPORATION PTY. LIMITED
Model
Bruxogard Soft
Catalog number
BruxS
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924974000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924974000THE TMJ APPLIANCEMyofunctional Research Corp. Pty. , Ltd.1993-06-23KMY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19330944001695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1933094400169519330944001695

GMDN Terms#

Term, Definition table
TermDefinition
Removable dental occlusal splint, preformedA rigid or flexible prefabricated device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporo-mandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is removable by the patient (e.g., during meals), and is typically made of standard, preformed materials that are not moulded, or intended to be moulded to a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
742030310
Device count
1
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
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

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