FDA.reportPublic FDA data

Premium Line

Primary DI
D829665035110M0051
Brand
Premium Line
Company
EC Certification Service GmbH
Model
665-0351-10M
Device description
Clear MBT 0.018 MAN 2 BI R HK SM
Published
2026-05-26
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
D829665035110M0051PrimaryHIBCC0
D829665035110M0Unit 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
D8294104C1Premium Line4104C2026-07-09
D8294210TL1Premium Line4210TL2026-07-09
D8294210TLE1Premium Line4210TLE2026-07-09
D8294221C1Premium Line4221C2026-07-09
D82944102721000051Premium Line441-0272-1002026-07-09
D82944102721000101Premium Line441-0272-1002026-07-09
D82944102721000501Premium Line441-0272-1002026-07-09
D82944102821000051Premium Line441-0282-1002026-07-09
D82944102821000101Premium Line441-0282-1002026-07-09
D82944102821000501Premium Line441-0282-1002026-07-09
D82944102821900051Premium Line441-0282-1902026-07-09
D82944102821900101Premium Line441-0282-1902026-07-09
D82944102821900501Premium Line441-0282-1902026-07-09
D82944103120000051Premium Line441-0312-0002026-07-09
D82944103120000101Premium Line441-0312-0002026-07-09
D82944103120000501Premium Line441-0312-0002026-07-09
D82944103120900051Premium Line441-0312-0902026-07-09
D82944103120900101Premium Line441-0312-0902026-07-09
D82944103120900501Premium Line441-0312-0902026-07-09
D82944103121000051Premium Line441-0312-1002026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D8294104C1Premium LineEC Certification Service GmbHDYW2026-07-09
D8294210TL1Premium LineEC Certification Service GmbHDYW2026-07-09
D8294210TLE1Premium LineEC Certification Service GmbHDYW2026-07-09
D8294221C1Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102721000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102721000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102721000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821900101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821900501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120900101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120900501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121900101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121900501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220900101Premium LineEC Certification Service GmbHDYW2026-07-09