FDA.reportPublic FDA data

Premium Line

Primary DI
D82966103111000101
Brand
Premium Line
Company
EC Certification Service GmbH
Model
661-0311-100
Device description
Clear Roth 0.018 MAN 1 BI R HK
Published
2026-06-08
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
D82966103111000101PrimaryHIBCC0
D82966103111000Unit 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
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
D82966101520000051Premium Line661-0152-0002026-06-08
D82966101520000101Premium Line661-0152-0002026-06-08
D82966101520000501Premium Line661-0152-0002026-06-08
D829661015200M0051Premium Line661-0152-00M2026-06-08
D829661015200M0101Premium Line661-0152-00M2026-06-08
D829661015200M0501Premium Line661-0152-00M2026-06-08
D82966101520900051Premium Line661-0152-0902026-06-08
D82966101520900101Premium Line661-0152-0902026-06-08
D82966101520900501Premium Line661-0152-0902026-06-08
D82966101620000051Premium Line661-0162-0002026-06-08
D82966101620000101Premium Line661-0162-0002026-06-08
D82966101620000501Premium Line661-0162-0002026-06-08
D829661016200M0051Premium Line661-0162-00M2026-06-08
D829661016200M0101Premium Line661-0162-00M2026-06-08
D829661016200M0501Premium Line661-0162-00M2026-06-08
D82966101620900051Premium Line661-0162-0902026-06-08
D82966101620900101Premium Line661-0162-0902026-06-08
D82966101620900501Premium Line661-0162-0902026-06-08
D82966101720000051Premium Line661-0172-0002026-06-08
D82966101720000101Premium Line661-0172-0002026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D82966101520000051Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101520000101Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101520000501Premium LineEC Certification Service GmbHDYW2026-06-08
D829661015200M0051Premium LineEC Certification Service GmbHDYW2026-06-08
D829661015200M0101Premium LineEC Certification Service GmbHDYW2026-06-08
D829661015200M0501Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101520900051Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101520900101Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101520900501Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101620000051Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101620000101Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101620000501Premium LineEC Certification Service GmbHDYW2026-06-08
D829661016200M0051Premium LineEC Certification Service GmbHDYW2026-06-08
D829661016200M0101Premium LineEC Certification Service GmbHDYW2026-06-08
D829661016200M0501Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101620900051Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101620900101Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101620900501Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101720000051Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101720000101Premium LineEC Certification Service GmbHDYW2026-06-08
D82966101720000501Premium LineEC Certification Service GmbHDYW2026-06-08
D829661017200M0051Premium LineEC Certification Service GmbHDYW2026-06-08
D829661017200M0101Premium LineEC Certification Service GmbHDYW2026-06-08
D829661017200M0501Premium LineEC Certification Service GmbHDYW2026-06-08
D82966103110000101Premium LineEC Certification Service GmbHDYW2026-06-08
D82966103110000501Premium LineEC Certification Service GmbHDYW2026-06-08
D829661031100M0051Premium LineEC Certification Service GmbHDYW2026-06-08
D829661031100M0101Premium LineEC Certification Service GmbHDYW2026-06-08
D829661031100M0501Premium LineEC Certification Service GmbHDYW2026-06-08
D82966103111000051Premium LineEC Certification Service GmbHDYW2026-06-08