FDA.report

Sunshine Diamonds

Primary DI
ESUN3061
Brand
Sunshine Diamonds
Company
Dr. Hopf GmbH & Co. KG
Model
306
Device description
Separating strips
Published
2023-06-23
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

Related Records

Product Codes

CodeName
EHMStrip, Polishing Agent

Product Code Classifications

CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESUN3068PrimaryHIBCC0
ESUN3061Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental abrasive strip, single-useA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
322126798
Device count
12
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

Primary DIBrandModelCatalogPublished
ESUN379P3140211Sunshine Diamonds379P3140212025-04-29
ESUN379P314021Sunshine Diamonds379P3140212025-04-29
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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