FDA.reportPublic FDA data

ITA.O

Primary DI
08052675320060
Brand
ITA.O
Company
ITA.O ITALIAN ORTHODONTIC SYSTEM SRL
Model
Maschera facciale ortodontica MAXI Blu
Catalog number
IT17-001B
Published
2021-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZBHeadgear, Extraoral, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZBHeadgear, Extraoral, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202855000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202855000Orthodontic FacemaskIta.O Italian Orthodontic System S.R.L.2021-06-21DZB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052675320060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052675320060080526753200608052675320060

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic extraoral headgearA dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
513891569
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052675320008ITA.OMaschera facciale ortodontica - MINI - BiancoIT17-0022021-06-30
08052675320015ITA.OMaschera facciale ortodontica - MINI - BluIT17-002B2021-06-30
08052675320022ITA.OMaschera facciale ortodontica - MINI - GialloIT17-002G2021-06-30
08052675320039ITA.OMaschera facciale ortodontica - MINI - RossoIT17-002R2021-06-30
08052675320046ITA.OMaschera facciale ortodontica - MINI - VerdeIT17-002V2021-06-30
08052675320053ITA.OMaschera facciale ortodontica - MAXI - BiancoIT17-0012021-06-30
08052675320077ITA.OMaschera facciale ortodontica - MAXI - GialloIT17-001G2021-06-30
08052675320084ITA.OMaschera facciale ortodontica - MAXI - RossoIT17-001R2021-06-30
08052675320091ITA.OMaschera facciale ortodontica - MAXI - VerdeIT17-001V2021-06-30

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Primary DI, Brand, Company table
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