FDA.reportPublic FDA data

Sunshine Diamonds

Primary DI
ESUNC33L3140125
Brand
Sunshine Diamonds
Company
Dr. Hopf GmbH & Co. KG
Model
C33L 314 012
Device description
Carbide bur
Published
2023-07-23
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
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESUNC33L3140125PrimaryHIBCC0
ESUNC33L3140121Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. 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
5
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

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Primary DI, Brand, Company table
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