FDA.reportPublic FDA data

Premium Line

Primary DI
D829665015100M0051
Brand
Premium Line
Company
EC Certification Service GmbH
Model
665-0151-00M
Device description
Clear MBT 0.018 MAX CEN R SM
Published
2026-05-07
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
DYWBracket, Plastic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D829665015100M0051PrimaryHIBCC0
D829665015100M0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, plastic, single-useA plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep away from sunlight.

Regulatory Flags#

DUNS number
300669699
Device count
5
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8294104C1Premium Line4104C2026-07-09
D8294210TL1Premium Line4210TL2026-07-09
D8294210TLE1Premium Line4210TLE2026-07-09
D8294221C1Premium Line4221C2026-07-09
D82944102721000051Premium Line441-0272-1002026-07-09
D82944102721000101Premium Line441-0272-1002026-07-09
D82944102721000501Premium Line441-0272-1002026-07-09
D82944102821000051Premium Line441-0282-1002026-07-09
D82944102821000101Premium Line441-0282-1002026-07-09
D82944102821000501Premium Line441-0282-1002026-07-09
D82944102821900051Premium Line441-0282-1902026-07-09
D82944102821900101Premium Line441-0282-1902026-07-09
D82944102821900501Premium Line441-0282-1902026-07-09
D82944103120000051Premium Line441-0312-0002026-07-09
D82944103120000101Premium Line441-0312-0002026-07-09
D82944103120000501Premium Line441-0312-0002026-07-09
D82944103120900051Premium Line441-0312-0902026-07-09
D82944103120900101Premium Line441-0312-0902026-07-09
D82944103120900501Premium Line441-0312-0902026-07-09
D82944103121000051Premium Line441-0312-1002026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D8294104C1Premium LineEC Certification Service GmbHDYW2026-07-09
D8294210TL1Premium LineEC Certification Service GmbHDYW2026-07-09
D8294210TLE1Premium LineEC Certification Service GmbHDYW2026-07-09
D8294221C1Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102721000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102721000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102721000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821900101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821900501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120900101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120900501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121900101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121900501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220900101Premium LineEC Certification Service GmbHDYW2026-07-09