FDA.reportPublic FDA data

Premium Line

Primary DI
D82944101610000501
Brand
Premium Line
Company
EC Certification Service GmbH
Model
441-0161-000
Device description
Shark SL Roth 0.018 U L 1
Published
2026-07-06
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
D82944101610000501PrimaryHIBCC0
D82944101610000Unit 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
D82944101510000051Premium Line441-0151-0002026-07-06
D82944101510000101Premium Line441-0151-0002026-07-06
D82944101510000501Premium Line441-0151-0002026-07-06
D82944101510900051Premium Line441-0151-0902026-07-06
D82944101510900101Premium Line441-0151-0902026-07-06
D82944101510900501Premium Line441-0151-0902026-07-06
D82944101610000051Premium Line441-0161-0002026-07-06
D82944101610000101Premium Line441-0161-0002026-07-06
D82944502021900051Premium Line445-0202-1902026-07-06
D82944502021900101Premium Line445-0202-1902026-07-06
D82944502021900501Premium Line445-0202-1902026-07-06
D82944502720000051Premium Line445-0272-0002026-07-06
D82944502720000101Premium Line445-0272-0002026-07-06
D82944502720000501Premium Line445-0272-0002026-07-06
D82944502720900051Premium Line445-0272-0902026-07-06
D82944502720900101Premium Line445-0272-0902026-07-06
D82944502720900501Premium Line445-0272-0902026-07-06
D82944502721000051Premium Line445-0272-1002026-07-06
D82944502721000101Premium Line445-0272-1002026-07-06
D82944502721000501Premium Line445-0272-1002026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D82944101510000051Premium LineEC Certification Service GmbHDYW2026-07-06
D82944101510000101Premium LineEC Certification Service GmbHDYW2026-07-06
D82944101510000501Premium LineEC Certification Service GmbHDYW2026-07-06
D82944101510900051Premium LineEC Certification Service GmbHDYW2026-07-06
D82944101510900101Premium LineEC Certification Service GmbHDYW2026-07-06
D82944101510900501Premium LineEC Certification Service GmbHDYW2026-07-06
D82944101610000051Premium LineEC Certification Service GmbHDYW2026-07-06
D82944101610000101Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502021900051Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502021900101Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502021900501Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502720000051Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502720000101Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502720000501Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502720900051Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502720900101Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502720900501Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502721000051Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502721000101Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502721000501Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502721900051Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502721900101Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502721900501Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502820000051Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502820000101Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502820000501Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502820900051Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502820900101Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502820900501Premium LineEC Certification Service GmbHDYW2026-07-06
D82944502821000051Premium LineEC Certification Service GmbHDYW2026-07-06