FDA.reportPublic FDA data

Premium Line

Primary DI
D82966512410000501
Brand
Premium Line
Company
EC Certification Service GmbH
Model
665-1241-000
Device description
Clear MBT 0.018 MAX 1,2 BI R/L
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
D82966512410000501PrimaryHIBCC0
D82966512410000Unit 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
50
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D82966101520000051Premium Line661-0152-0002026-06-08
D82966101520000101Premium Line661-0152-0002026-06-08
D82966101520000501Premium Line661-0152-0002026-06-08
D829661015200M0051Premium Line661-0152-00M2026-06-08
D829661015200M0101Premium Line661-0152-00M2026-06-08
D829661015200M0501Premium Line661-0152-00M2026-06-08
D82966101520900051Premium Line661-0152-0902026-06-08
D82966101520900101Premium Line661-0152-0902026-06-08
D82966101520900501Premium Line661-0152-0902026-06-08
D82966101620000051Premium Line661-0162-0002026-06-08
D82966101620000101Premium Line661-0162-0002026-06-08
D82966101620000501Premium Line661-0162-0002026-06-08
D829661016200M0051Premium Line661-0162-00M2026-06-08
D829661016200M0101Premium Line661-0162-00M2026-06-08
D829661016200M0501Premium Line661-0162-00M2026-06-08
D82966101620900051Premium Line661-0162-0902026-06-08
D82966101620900101Premium Line661-0162-0902026-06-08
D82966101620900501Premium Line661-0162-0902026-06-08
D82966101720000051Premium Line661-0172-0002026-06-08
D82966101720000101Premium Line661-0172-0002026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D82966101520000051Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101520000101Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101520000501Premium LineEC Certification Service GmbHDYW2026-06-08
D829661015200M0051Premium LineEC Certification Service GmbHDYW2026-06-08
D829661015200M0101Premium LineEC Certification Service GmbHDYW2026-06-08
D829661015200M0501Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101520900051Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101520900101Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101520900501Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101620000051Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101620000101Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101620000501Premium LineEC Certification Service GmbHDYW2026-06-08
D829661016200M0051Premium LineEC Certification Service GmbHDYW2026-06-08
D829661016200M0101Premium LineEC Certification Service GmbHDYW2026-06-08
D829661016200M0501Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101620900051Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101620900101Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101620900501Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101720000051Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101720000101Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101720000501Premium LineEC Certification Service GmbHDYW2026-06-08
D829661017200M0051Premium LineEC Certification Service GmbHDYW2026-06-08
D829661017200M0101Premium LineEC Certification Service GmbHDYW2026-06-08
D829661017200M0501Premium LineEC Certification Service GmbHDYW2026-06-08
D82966103110000101Premium LineEC Certification Service GmbHDYW2026-06-08
D82966103110000501Premium LineEC Certification Service GmbHDYW2026-06-08
D829661031100M0051Premium LineEC Certification Service GmbHDYW2026-06-08
D829661031100M0101Premium LineEC Certification Service GmbHDYW2026-06-08
D829661031100M0501Premium LineEC Certification Service GmbHDYW2026-06-08
D82966103111000051Premium LineEC Certification Service GmbHDYW2026-06-08