FDA.reportPublic FDA data

Premium Line

Primary DI
D82966501820000501
Brand
Premium Line
Company
EC Certification Service GmbH
Model
665-0182-000
Device description
Clear MBT 0.022 MAX LAT L
Published
2026-05-28
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
D82966501820000501PrimaryHIBCC0
D82966501820000Unit 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
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
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
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
D82966501921000051Premium Line665-0192-1002026-05-28

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
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
D829665020200M0101Premium LineEC Certification Service GmbHDYW2026-05-28