FDA.reportPublic FDA data

Premium Line

Primary DI
D829480005C1
Brand
Premium Line
Company
EC Certification Service GmbH
Model
480-005C
Device description
Shark 80 Kit Roth 0.016 U 5/5 HK3 / L 5/5 HK 3,4
Published
2026-07-30
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
D829480005C1PrimaryHIBCC0

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
1
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
D82944S01520300051Premium Line44S-0152-0302026-07-30
D82944S01520300101Premium Line44S-0152-0302026-07-30
D829480001C1Premium Line480-001C2026-07-30
D829480002C1Premium Line480-002C2026-07-30
D829480003C1Premium Line480-003C2026-07-30
D82948001500000051Premium Line480-0150-0002026-07-30
D82948001500000101Premium Line480-0150-0002026-07-30
D82948001500000501Premium Line480-0150-0002026-07-30
D82948001600000051Premium Line480-0160-0002026-07-30
D82948001600000101Premium Line480-0160-0002026-07-30
D82948001600000501Premium Line480-0160-0002026-07-30
D82948001700000051Premium Line480-0170-0002026-07-30
D82948001700000101Premium Line480-0170-0002026-07-30
D82948001700000501Premium Line480-0170-0002026-07-30
D82948001800000051Premium Line480-0180-0002026-07-30
D82948001800000101Premium Line480-0180-0002026-07-30
D82948001800000501Premium Line480-0180-0002026-07-30
D82948001901000051Premium Line480-0190-1002026-07-30
D82948001901000101Premium Line480-0190-1002026-07-30
D82948001901000501Premium Line480-0190-1002026-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D82944S01520300051Premium LineEC Certification Service GmbHDYW2026-07-30
D82944S01520300101Premium LineEC Certification Service GmbHDYW2026-07-30
D829480001C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480002C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480003C1Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001600000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001600000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001600000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001700000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001700000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001700000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001800000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001800000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001800000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001901000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001901000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001901000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002001000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002001000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002001000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002701000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002701000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002701000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002801000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002801000101Premium LineEC Certification Service GmbHDYW2026-07-30
D82948002801000501Premium LineEC Certification Service GmbHDYW2026-07-30
D82948003101000051Premium LineEC Certification Service GmbHDYW2026-07-30