FDA.report

ADITEK

Primary DI
07899439233201
Brand
ADITEK
Company
Aditek do Brasil Ltda
Model
04.01.1345
Device description
Molar Band UR 34,5 w/10
Published
2023-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ECIBand, Elastic, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899439233201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899439233201078994392332017899439233201

GMDN Terms

TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Regulatory Flags

DUNS number
900761396
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
true
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 DIBrandModelCatalogPublished
07899439262157ADITEK09.12.05622024-05-03
07899439262164ADITEK09.12.05662024-05-03
07899439262171ADITEK09.12.05752024-05-03
07899439262188ADITEK09.12.05852024-05-03
07899439262195ADITEK09.12.05952024-05-03
07899439262218ADITEK09.12.06122024-05-03
07899439262225ADITEK09.12.06142024-05-03
07899439262232ADITEK09.12.06162024-05-03
07899439262249ADITEK09.12.06182024-05-03
07899439262256ADITEK09.12.06202024-05-03
07899439262263ADITEK09.12.06622024-05-03
07899439262270ADITEK09.12.06662024-05-03
07899439262294ADITEK09.12.06852024-05-03
07899439262300ADITEK09.12.06952024-05-03
07899439262317ADITEK09.12.06252024-05-03
07899439262737ADITEK09.13.05142024-05-03
07899439262751ADITEK09.13.05182024-05-03
07899439262843ADITEK09.13.05162024-05-03
07899439268302ADITEK09.12.0525.62024-05-03
07899439268319ADITEK09.12.0562.62024-05-03

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