FDA.report

Sunshine Diamonds

Primary DI
ESUNFG9419ZR2
Brand
Sunshine Diamonds
Company
Dr. Hopf GmbH & Co. KG
Model
FG 9419ZR
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
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EHLPoint, Abrasive

Product Code Classifications

CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
ESUNFG9419ZR2PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
322126798
Device count
1
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

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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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