FDA.reportPublic FDA data

Premium Line

Primary DI
D829665020100M0101
Brand
Premium Line
Company
EC Certification Service GmbH
Model
665-0201-00M
Device description
Clear MBT 0.018 MAX CUS L 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
D829665020100M0101PrimaryHIBCC0
D829665020100M0Unit 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
D829661019100M0051Premium Line661-0191-00M2026-06-02
D829661019100M0101Premium Line661-0191-00M2026-06-02
D829661019100M0501Premium Line661-0191-00M2026-06-02
D82966101911000051Premium Line661-0191-1002026-06-02
D82966101911000101Premium Line661-0191-1002026-06-02
D82966101911000501Premium Line661-0191-1002026-06-02
D829661019110M0051Premium Line661-0191-10M2026-06-02
D829661019110M0101Premium Line661-0191-10M2026-06-02
D829661019110M0501Premium Line661-0191-10M2026-06-02
D82966102010000051Premium Line661-0201-0002026-06-02
D82966102010000101Premium Line661-0201-0002026-06-02
D82966102010000501Premium Line661-0201-0002026-06-02
D829661020100M0051Premium Line661-0201-00M2026-06-02
D829661020100M0101Premium Line661-0201-00M2026-06-02
D829661020100M0501Premium Line661-0201-00M2026-06-02
D82966102011000051Premium Line661-0201-1002026-06-02
D82966102011000101Premium Line661-0201-1002026-06-02
D82966102011000501Premium Line661-0201-1002026-06-02
D829661020110M0051Premium Line661-0201-10M2026-06-02
D829661020110M0101Premium Line661-0201-10M2026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D829661019100M0051Premium LineEC Certification Service GmbHDYW2026-06-02
D829661019100M0101Premium LineEC Certification Service GmbHDYW2026-06-02
D829661019100M0501Premium LineEC Certification Service GmbHDYW2026-06-02
D82966101911000051Premium LineEC Certification Service GmbHDYW2026-06-02
D82966101911000101Premium LineEC Certification Service GmbHDYW2026-06-02
D82966101911000501Premium LineEC Certification Service GmbHDYW2026-06-02
D829661019110M0051Premium LineEC Certification Service GmbHDYW2026-06-02
D829661019110M0101Premium LineEC Certification Service GmbHDYW2026-06-02
D829661019110M0501Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102010000051Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102010000101Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102010000501Premium LineEC Certification Service GmbHDYW2026-06-02
D829661020100M0051Premium LineEC Certification Service GmbHDYW2026-06-02
D829661020100M0101Premium LineEC Certification Service GmbHDYW2026-06-02
D829661020100M0501Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102011000051Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102011000101Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102011000501Premium LineEC Certification Service GmbHDYW2026-06-02
D829661020110M0051Premium LineEC Certification Service GmbHDYW2026-06-02
D829661020110M0101Premium LineEC Certification Service GmbHDYW2026-06-02
D829661020110M0501Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102710000051Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102710000101Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102710000501Premium LineEC Certification Service GmbHDYW2026-06-02
D829661027100M0051Premium LineEC Certification Service GmbHDYW2026-06-02
D829661027100M0101Premium LineEC Certification Service GmbHDYW2026-06-02
D829661027100M0501Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102711000051Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102711000101Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102711000501Premium LineEC Certification Service GmbHDYW2026-06-02