FDA.reportPublic FDA data

Premium Line

Primary DI
D82966102011000051
Brand
Premium Line
Company
EC Certification Service GmbH
Model
661-0201-100
Device description
Clear Roth 0.018 MAX CUS L HK
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
D82966102011000051PrimaryHIBCC0
D82966102011000Unit 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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 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
D82966102011000101Premium Line661-0201-1002026-06-02
D82966102011000501Premium Line661-0201-1002026-06-02
D829661020110M0051Premium Line661-0201-10M2026-06-02
D829661020110M0101Premium Line661-0201-10M2026-06-02
D829661020110M0501Premium 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
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
D829661027110M0051Premium LineEC Certification Service GmbHDYW2026-06-02