FDA.reportPublic FDA data

Premium Line

Primary DI
D829665018100M0101
Brand
Premium Line
Company
EC Certification Service GmbH
Model
665-0181-00M
Device description
Clear MBT 0.018 MAX LAT L SM
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
D829665018100M0101PrimaryHIBCC0
D829665018100M0Unit 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.

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
D829665016200M0101Premium Line665-0162-00M2026-05-28
D829665016200M0501Premium Line665-0162-00M2026-05-28
D82966501720000051Premium Line665-0172-0002026-05-28
D82966501720000101Premium Line665-0172-0002026-05-28
D82966501720000501Premium Line665-0172-0002026-05-28
D829665017200M0051Premium Line665-0172-00M2026-05-28
D829665017200M0101Premium Line665-0172-00M2026-05-28
D829665017200M0501Premium Line665-0172-00M2026-05-28
D82966501820000051Premium Line665-0182-0002026-05-28
D82966501820000101Premium Line665-0182-0002026-05-28
D82966501820000501Premium Line665-0182-0002026-05-28
D829665018200M0051Premium Line665-0182-00M2026-05-28
D829665018200M0101Premium Line665-0182-00M2026-05-28
D829665018200M0501Premium Line665-0182-00M2026-05-28
D82966501920000051Premium Line665-0192-0002026-05-28
D82966501920000101Premium Line665-0192-0002026-05-28
D82966501920000501Premium Line665-0192-0002026-05-28
D829665019200M0051Premium Line665-0192-00M2026-05-28
D829665019200M0101Premium Line665-0192-00M2026-05-28
D829665019200M0501Premium Line665-0192-00M2026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D829665016200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665016200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501720000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501720000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501720000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665017200M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665017200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665017200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501820000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501820000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501820000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665018200M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665018200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665018200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501920000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501920000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501920000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019200M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501921000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501921000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501921000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019210M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019210M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019210M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966502020000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966502020000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966502020000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665020200M0051Premium LineEC Certification Service GmbHDYW2026-05-28