FDA.report

Sunshine Diamonds

Primary DI
ESUNC13140181
Brand
Sunshine Diamonds
Company
Dr. Hopf GmbH & Co. KG
Model
C 1 314 018
Device description
Carbide bur
Published
2023-06-28
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
false

Related Records

Product Codes

CodeName
EJLBur, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESUNC13140185PrimaryHIBCC0
ESUNC13140181Unit of UseHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
322126798
Device count
5
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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ESUN801C2040231Sunshine Diamonds801C2040232025-04-29
ESUN801C204023Sunshine Diamonds801C2040232025-04-29
ESUN8312050141Sunshine Diamonds8312050142025-04-29
ESUN831205014Sunshine Diamonds8312050142025-04-29
ESUN8313140141Sunshine Diamonds831 314 0142025-04-29
ESUN831314014Sunshine Diamonds831 314 0142025-04-29
ESUN835KRF3140081Sunshine Diamonds835KRF3140082025-04-29
ESUN835KRF314008Sunshine Diamonds835KRF3140082025-04-29
ESUN8372040181Sunshine Diamonds8372040182025-04-29
ESUN837204018Sunshine Diamonds8372040182025-04-29
ESUN837KRM3140101Sunshine Diamonds837KRM3140102025-04-29
ESUN837KRM314010Sunshine Diamonds837KRM3140102025-04-29
ESUN846KRF3140181Sunshine Diamonds846KRF3140182025-04-29
ESUN846KRF314018Sunshine Diamonds846KRF3140182025-04-29
ESUN847KRF3140181Sunshine Diamonds847KRF3140182025-04-29
ESUN847KRF314018Sunshine Diamonds847KRF3140182025-04-29
ESUN8513140161Sunshine Diamonds8513140162025-04-29
ESUN851314016Sunshine Diamonds8513140162025-04-29

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