FDA.reportPublic FDA data

Sunshine Diamonds

Primary DI
ESUN888VF3140162
Brand
Sunshine Diamonds
Company
Dr. Hopf GmbH & Co. KG
Model
888VF314 016
Device description
Rotary diamond instruments
Published
2023-06-16
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
GZPStimulator, Mechanical, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZPStimulator, Mechanical, Evoked ResponseNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESUN888VF3140162PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
322126798
Device count
1
DM exempt
true
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
00840067103982Sierra SummitCADWELL INDUSTRIES, INC.GZP2024-11-15
00840067102848Sierra SummitCADWELL INDUSTRIES, INC.GZP2020-12-10
00840067100264Sierra SummitCADWELL INDUSTRIES, INC.GZP2019-01-08
00840067100011Sierra SummitCADWELL INDUSTRIES, INC.GZP2016-09-05
00840067100035Sierra SummitCADWELL INDUSTRIES, INC.GZP2016-09-05
00840067100097Sierra SummitCADWELL INDUSTRIES, INC.GZP2016-09-05
00840067100110Sierra Summit/AscentCADWELL INDUSTRIES, INC.GZP2016-09-05
00840067100127Sierra Summit/AscentCADWELL INDUSTRIES, INC.GZP2016-09-05
00840067100134Sierra AscentCADWELL INDUSTRIES, INC.GZP2016-09-05
00840067100141Sierra AscentCADWELL INDUSTRIES, INC.GZP2016-09-05
00840067100288Sierra SummitCADWELL INDUSTRIES, INC.GZP2016-09-05
00840067100301Sierra SummitCADWELL INDUSTRIES, INC.GZP2016-09-05
00840067100325Sierra SummitCADWELL INDUSTRIES, INC.GZP2016-09-05
00840067100332Sierra Summit/AscentCADWELL INDUSTRIES, INC.GZP2016-09-05
00840067100349Sierra AscentCADWELL INDUSTRIES, INC.GZP2016-09-05
00840067100356Sierra Summit/AscentCADWELL INDUSTRIES, INC.GZP2016-09-05
00840067100103Sierra SummitCADWELL INDUSTRIES, INC.GZP2016-09-05