FDA.reportPublic FDA data

LMDental

Primary DI
06438311231501
Brand
LMDental
Company
LM-Dental
Model
94445HS
Catalog number
94445HS
Device description
My LM-Activator 45 High Short
Published
2024-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
06438311231501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438311231501064383112315016438311231501

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
401969969
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438311708775LMDental465-495XSI2026-05-25
06438311708782LMDental465-495ES2026-05-25
06438311708799LMDental465-495EST2026-05-25
06438311708805LMDental465-495ESTU2026-05-25
06438311227221LMDental128-128SDESTU2026-03-26
06438311227771LMDental128-128SDEST2026-03-26
06438311708676LMDental444-445XSIGC2026-03-23
06438311708683LMDental473-753XSIGC2026-03-23
06438311708690LMDental473-753XSI2026-03-23
06438311708706LMDental473-753ES2026-03-23
06438311708713LMDental473-753EST2026-03-23
06438311708720LMDental473-753ESTU2026-03-23
06438311708737LMDental743-753XSI2026-03-23
06438311708744LMDental743-753ES2026-03-23
06438311708751LMDental743-753EST2026-03-23
06438311708768LMDental743-753ESTU2026-03-23
06438311207407LMDental211-212AFES2025-12-31
06438311208251LMDental213-214AFES2025-12-31
06438311708034LMDental464-494DDES2025-10-10
06438311708041LMDental431-433DDES2025-10-10

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