FDA.reportPublic FDA data

Sunshine Diamonds

Primary DI
ESUN100W92812
Brand
Sunshine Diamonds
Company
Dr. Hopf GmbH & Co. KG
Model
100W 9281
Device description
Dental Polisher
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EHLPoint, Abrasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESUN100W92812PrimaryHIBCC0
ESUN100W92811Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive point, reusableA rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
322126798
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ESUN379P3140215Sunshine Diamonds379P3140212025-04-29
ESUN801C2040235Sunshine Diamonds801C2040232025-04-29
ESUN8312050145Sunshine Diamonds8312050142025-04-29
ESUN8313140145Sunshine Diamonds831 314 0142025-04-29
ESUN835KRF3140085Sunshine Diamonds835KRF3140082025-04-29
ESUN8372040185Sunshine Diamonds8372040182025-04-29
ESUN837KRM3140105Sunshine Diamonds837KRM3140102025-04-29
ESUN846KRF3140185Sunshine Diamonds846KRF3140182025-04-29
ESUN847KRF3140185Sunshine Diamonds847KRF3140182025-04-29
ESUN8513140165Sunshine Diamonds8513140162025-04-29
ESUN8563130165Sunshine Diamonds8563130162025-04-29
ESUN857F3140145Sunshine Diamonds857F3140142025-04-29
ESUN858F3140105Sunshine Diamonds858F3140102025-04-29
ESUN858F3140125Sunshine Diamonds858F3140122025-04-29
ESUN858F3140145Sunshine Diamonds858F3140142025-04-29
ESUN858F3140165Sunshine Diamonds858F3140162025-04-29
ESUN880SC3120145Sunshine Diamonds880SC3120142025-04-29
ESUN880SC3130145Sunshine Diamonds880SC3130142025-04-29
ESUN8813140085Sunshine Diamonds8813140082025-04-29
ESUN881F3140085Sunshine Diamonds881F3140082025-04-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07897990301155PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301209PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990301216PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399756PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399763PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399770PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399787PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399794PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399800PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399817PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399824PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399831PRAXIS DIAMONDTDV DENTAL LTDAEHL2026-05-18
07897990399848PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399855PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399862PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399886PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399893PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399909PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399916PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399923PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399930PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399947PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
07897990399954PRAXIS POLISHERSTDV DENTAL LTDAEHL2026-05-18
08404535025101Brasseler USAPeter Brasseler Holdings, LLCEHL2026-05-11
07630049901094Diacomp flame, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049901773Diabrush cup, pu: 2 pcsDiaswiss SAEHL2023-10-02
07630049984073Diaceram 2-step cup, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049984554Diabrownies flame, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049984578Diabrownies cup, pu: 6 pcsDiaswiss SAEHL2023-10-02
07630049984592Diabrownies flame, pu: 6 pcsDiaswiss SAEHL2023-10-02