FDA.reportPublic FDA data

Premium Line

Primary DI
D829665019110M0101
Brand
Premium Line
Company
EC Certification Service GmbH
Model
665-0191-10M
Device description
Clear MBT 0.018 MAX CUS R HK SM
Published
2026-05-21
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
D829665019110M0101PrimaryHIBCC0
D829665019110M0Unit 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
10
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D82944S01520300501Premium Line44S-0152-0302026-07-31
D82944S01620300051Premium Line44S-0162-0302026-07-31
D82944S01620300101Premium Line44S-0162-0302026-07-31
D82944S01620300501Premium Line44S-0162-0302026-07-31
D82944S01720300051Premium Line44S-0172-0302026-07-31
D82944S01720300101Premium Line44S-0172-0302026-07-31
D82944S01720300501Premium Line44S-0172-0302026-07-31
D82944S01820300051Premium Line44S-0182-0302026-07-31
D82944S01820300101Premium Line44S-0182-0302026-07-31
D82944S01820300501Premium Line44S-0182-0302026-07-31
D82944S01920300051Premium Line44S-0192-0302026-07-31
D82944S01920300101Premium Line44S-0192-0302026-07-31
D82944S01920300501Premium Line44S-0192-0302026-07-31
D82944S02020300051Premium Line44S-0202-0302026-07-31
D82944S02020300101Premium Line44S-0202-0302026-07-31
D82944S02020300501Premium Line44S-0202-0302026-07-31
D82955112411000051Premium Line551-1241-1002026-07-31
D82955112411000101Premium Line551-1241-1002026-07-31
D82955112411000501Premium Line551-1241-1002026-07-31
D82955112511000051Premium Line551-1251-1002026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D82944S01520300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01620300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01620300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01620300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01720300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01720300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01720300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01820300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01820300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01820300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01920300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01920300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01920300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S02020300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S02020300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S02020300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112411000051Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112411000101Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112411000501Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112511000051Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112511000101Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112511000501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01520300051Premium LineEC Certification Service GmbHDYW2026-07-30
D82944S01520300101Premium LineEC Certification Service GmbHDYW2026-07-30
D829480001C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480002C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480003C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480005C1Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000101Premium LineEC Certification Service GmbHDYW2026-07-30