FDA.reportPublic FDA data

EQUILIBRATORE SL3 YOUNG

Primary DI
08054154160402
Brand
EQUILIBRATORE SL3 YOUNG
Company
EPTAMED SRL
Model
SL3 YOUNG ORANGE
Catalog number
SL3Y ORANGE
Device description
Preformed orthodontic tooth positioner
Published
2026-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
08054154160402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054154160402080541541604028054154160402

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
434656580
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054154160013EQUILIBRATORE 1.01.0 BLUE1.0 BLUE2026-07-28
08054154160020EQUILIBRATORE 1.051.05 BLUE1.05 BLUE2026-07-28
08054154160037EQUILIBRATORE 1.11.1 BLUE1.1 BLUE2026-07-28
08054154160051EQUILIBRATORE 1.2 YOUNG1.2 YOUNG ORANGE1.2 Y ORANGE2026-07-28
08054154160143EQUILIBRATORE 3.23.2 ORANGE3.2 ORANGE2026-07-28
08054154160150EQULIBRATORE 3.33.3 ORANGE3.3 ORANGE2026-07-28
08054154160198EquiIlibratore C2C2 BLUEC2 BLUE2026-07-28
08054154160204Equilibratore C3C3 BlueC3 Blue2026-07-28
08054154160211Equilibratore C4C4 BlueC4 blue2026-07-28
08054154160228EQUILIBRATORE C3PC3P ORANGEC3P ORANGE2026-07-28
08054154160259EQUILIBRATORE E-FITE-FIT 2 BLUEE-FIT 22026-07-28
08054154160266EQUILIBRATORE E-FITE_FIT 3 BLUEE_FIT 3 BLUE2026-07-28
08054154160273EQUILIBRATORE E-FITE-FIT 4 BLUEE-FIT 4 BLUE2026-07-28
08054154160297FREEDOMFREEDOMFREEDOM2026-07-28
08054154160303EQUILIBRATORE GENIUS 3G3 BLUEG3 BLUE2026-07-28
08054154160334EQUILIBRATORE NIKI 1NIKI 1 AQUAMARINENIKI 1 AQUAMARINE2026-07-28
08054154160372EQUILIBRATORE 003003 ORANGE003 ORANGE2026-07-28
08054154160426EQUILIBRATORE U3U3 BLUEU3 BLUE2026-07-28
08054154160433EQUILIBRATORE U4U4 BLUEU4 BLUE2026-07-28
08054154160501EQULIBRATORE U2U2 BLUEU2 BLUE2026-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054154160013EQUILIBRATORE 1.0EPTAMED SRLKMY2026-07-28
08054154160020EQUILIBRATORE 1.05EPTAMED SRLKMY2026-07-28
08054154160037EQUILIBRATORE 1.1EPTAMED SRLKMY2026-07-28
08054154160051EQUILIBRATORE 1.2 YOUNGEPTAMED SRLKMY2026-07-28
08054154160143EQUILIBRATORE 3.2EPTAMED SRLKMY2026-07-28
08054154160150EQULIBRATORE 3.3EPTAMED SRLKMY2026-07-28
08054154160198EquiIlibratore C2EPTAMED SRLKMY2026-07-28
08054154160204Equilibratore C3EPTAMED SRLKMY2026-07-28
08054154160211Equilibratore C4EPTAMED SRLKMY2026-07-28
08054154160228EQUILIBRATORE C3PEPTAMED SRLKMY2026-07-28
08054154160259EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160266EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160273EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160297FREEDOMEPTAMED SRLKMY2026-07-28
08054154160303EQUILIBRATORE GENIUS 3EPTAMED SRLKMY2026-07-28
08054154160334EQUILIBRATORE NIKI 1EPTAMED SRLKMY2026-07-28
08054154160372EQUILIBRATORE 003EPTAMED SRLKMY2026-07-28
08054154160426EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154160433EQUILIBRATORE U4EPTAMED SRLKMY2026-07-28
08054154160501EQULIBRATORE U2EPTAMED SRLKMY2026-07-28
08054154160563EQUILIBRATORE GENIUSEPTAMED SRLKMY2026-07-28
08054154160761EQUILIBRATORE NIKI 2EPTAMED SRLKMY2026-07-28
08054154160815EQUILIBRATORE GENIUSEPTAMED SRLKMY2026-07-28
08054154160822EQUILIBRATORE GENIUS 2EPTAMED SRLKMY2026-07-28
08054154160945EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154160969EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154161089EQULIBRATORE 1.1EPTAMED SRLKMY2026-07-28
08054154161126EQUILIBRATORE C3P YOUNGEPTAMED SRLKMY2026-07-28
08054154161164EQULIBRATORE U4 YOUNGEPTAMED SRLKMY2026-07-28
08054154161287EQULIBRATORE 1.3EPTAMED SRLKMY2026-07-28