FDA.reportPublic FDA data

EQUILIBRATORE 1.0

Primary DI
08054154161041
Brand
EQUILIBRATORE 1.0
Company
EPTAMED SRL
Model
1.0 PINK
Catalog number
1.0 PINK
Device description
Preformed orthodontic tooth positioner
Published
2026-08-27
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
08054154161041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08054154161041080541541610418054154161041

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
08054154160044EQUILIBRATORE 1.21.2 ORANGE1.2 ORANGE2026-08-27
08054154160068EQULIBRATORE 1.31.3 ORANGE1.3 ORANGE2026-08-27
08054154160082EQUILIBRATORE 1.41.4 ORANGE1.4 ORANGE2026-08-27
08054154160242EQUILIBRATORE C4PC4P ORANGEC4P ORANGE2026-08-27
08054154161058EQUILIBRATORE 1.01.0 NEUTRAL1.0 NEUTRAL2026-08-27
08054154161065EQUILIBRATORE 1.051.05 PINK1.05 PINK2026-08-27
08054154161072EQUILIBRATORE 1.051.05 NEUTRAL1.05 NEUTRAL2026-08-27
08054154161096EQUILIBRATORE 1.11.1 NEUTRAL1.1 NEUTRAL2026-08-27
08054154161102EQUILIBRATORE 1.11.1 ORANGE1.1 ORANGE2026-08-27
08054154161218EQUILIBRATORE 1.21.2 WHITE1.2 WHITE2026-08-27
08054154161225EQUILIBRATORE 1.21.2 NEUTRAL1.2 NEUTRAL2026-08-27
08054154161232EQUILIBRATORE 1.21.2 GREEN1.2 GREEN2026-08-27
08054154161249EQUILIBRATORE 1.2-S1.2-S WHITE1.2-S WHITE2026-08-27
08054154161256EQUILIBRATORE 1.2-S1.2-S ORANGE1.2-S ORANGE2026-08-27
08054154161263EQUILIBRATORE 1.2-S1.2-S NEUTRAL1.2-S NEUTRAL2026-08-27
08054154161270EQUILIBRATORE 1.2-S1.2-S GREEN1.2-S GREEN2026-08-27
08054154161294EQUILIBRATORE 1.31.3 NEUTRAL1.3 NEUTRAL2026-08-27
08054154161300EQUILIBRATORE 1.31.3 GREEN1.3 GREEN2026-08-27
08054154161317EQUILIBRATORE 1.3-S1.3-S WHITE1.3-S WHITE2026-08-27
08054154161324EQUILIBRATORE 1.3-S1.3-S ORANGE1.3-S ORANGE2026-08-27

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
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
08054154161621EQUILIBRATORE C3EPTAMED SRLKMY2026-08-27