FDA.reportPublic FDA data

Premium Line

Primary DI
D82966501520000051
Brand
Premium Line
Company
EC Certification Service GmbH
Model
665-0152-000
Device description
Clear MBT 0.022 MAX CEN R
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
D82966501520000051PrimaryHIBCC0
D82966501520000Unit 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
D82966501520000101Premium Line665-0152-0002026-05-26
D82966501520000501Premium Line665-0152-0002026-05-26
D829665015200M0051Premium Line665-0152-00M2026-05-26
D829665015200M0101Premium Line665-0152-00M2026-05-26
D829665015200M0501Premium Line665-0152-00M2026-05-26
D82966501620000051Premium Line665-0162-0002026-05-26
D82966501620000101Premium Line665-0162-0002026-05-26
D82966501620000501Premium Line665-0162-0002026-05-26
D829665016200M0051Premium Line665-0162-00M2026-05-26
D82966503110000501Premium Line665-0311-0002026-05-26
D829665031100M0051Premium Line665-0311-00M2026-05-26
D829665031100M0101Premium Line665-0311-00M2026-05-26
D829665031100M0501Premium Line665-0311-00M2026-05-26
D82966503111000051Premium Line665-0311-1002026-05-26
D82966503111000101Premium Line665-0311-1002026-05-26
D82966503111000501Premium Line665-0311-1002026-05-26
D829665031110M0051Premium Line665-0311-10M2026-05-26
D829665031110M0101Premium Line665-0311-10M2026-05-26
D829665031110M0501Premium Line665-0311-10M2026-05-26
D82966503210000051Premium Line665-0321-0002026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D82966501520000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501520000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665015200M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D829665015200M0101Premium LineEC Certification Service GmbHDYW2026-05-26
D829665015200M0501Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501620000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501620000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501620000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665016200M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503110000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031100M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031100M0101Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031100M0501Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503111000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503111000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503111000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031110M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031110M0101Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031110M0501Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503210000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503210000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503210000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665032100M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D829665032100M0101Premium LineEC Certification Service GmbHDYW2026-05-26
D829665032100M0501Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503211000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503211000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503211000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665032110M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D829665032110M0101Premium LineEC Certification Service GmbHDYW2026-05-26