FDA.reportPublic FDA data

Premium Line

Primary DI
D82966501710000101
Brand
Premium Line
Company
EC Certification Service GmbH
Model
665-0171-000
Device description
Clear MBT 0.018 MAX LAT R
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
D82966501710000101PrimaryHIBCC0
D82966501710000Unit 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
D82966101720900051Premium Line661-0172-0902026-06-09
D82966101720900101Premium Line661-0172-0902026-06-09
D82966101720900501Premium Line661-0172-0902026-06-09
D82966101820000051Premium Line661-0182-0002026-06-09
D82966101820000101Premium Line661-0182-0002026-06-09
D82966101820000501Premium Line661-0182-0002026-06-09
D829661018200M0051Premium Line661-0182-00M2026-06-09
D829661018200M0101Premium Line661-0182-00M2026-06-09
D829661018200M0501Premium Line661-0182-00M2026-06-09
D82966101820900051Premium Line661-0182-0902026-06-09
D82966101820900101Premium Line661-0182-0902026-06-09
D82966101820900501Premium Line661-0182-0902026-06-09
D82966101920000051Premium Line661-0192-0002026-06-09
D82966101920000101Premium Line661-0192-0002026-06-09
D82966101920000501Premium Line661-0192-0002026-06-09
D829661019200M0051Premium Line661-0192-00M2026-06-09
D829661019200M0101Premium Line661-0192-00M2026-06-09
D829661019200M0501Premium Line661-0192-00M2026-06-09
D82966101921000051Premium Line661-0192-1002026-06-09
D82966101921000101Premium Line661-0192-1002026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D82966101720900051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101720900101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101720900501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820000051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820000101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820000501Premium LineEC Certification Service GmbHDYW2026-06-09
D829661018200M0051Premium LineEC Certification Service GmbHDYW2026-06-09
D829661018200M0101Premium LineEC Certification Service GmbHDYW2026-06-09
D829661018200M0501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820900051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820900101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820900501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101920000051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101920000101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101920000501Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019200M0051Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019200M0101Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019200M0501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921000051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921000101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921000501Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019210M0051Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019210M0101Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019210M0501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921900051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921900101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921900501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966102020000051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966102020000101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966102020000501Premium LineEC Certification Service GmbHDYW2026-06-09