FDA.reportPublic FDA data

DIATECH Diamonds

Primary DI
07630243609383
Brand
DIATECH Diamonds
Company
Dent4You AG
Model
60032034
Catalog number
60032034
Device description
DIATECH Diamonds, G836R Rounded Edge Cylinder 008-06.0-M, FG, 5pcs
Published
2023-08-24
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

Product Codes#

Code, Name table
CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630243615032PrimaryGS10
07630243609383Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630243615032076302436150327630243615032
07630243609383076302436093837630243609383

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480152811
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640397420390HIP Ultra Cleaning SolutionCS-HIPC-UCS-HIPC-U2026-05-06
07640397420406HIP Cleaning SolutionCS-HIPLCS-HIPL2026-05-06
07640397422332HIP Cleaning SolutionCS-HIPTCS-HIPT2026-02-11
07630243627981BRILLIANT EverGlow60019697600196972026-04-28
07630243627998BRILLIANT EverGlow60019698600196982026-04-28
07630243628001BRILLIANT EverGlow60019699600196992026-04-28
07630243628018BRILLIANT EverGlow60019700600197002026-04-28
07630243628025BRILLIANT EverGlow60019701600197012026-04-28
07630243628032BRILLIANT EverGlow60019702600197022026-04-28
07630243628049BRILLIANT EverGlow60019703600197032026-04-28
07630243628056BRILLIANT EverGlow60019704600197042026-04-28
07630243628063BRILLIANT EverGlow60019705600197052026-04-28
07630243628070BRILLIANT EverGlow60019706600197062026-04-28
07630243628087BRILLIANT EverGlow60019707600197072026-04-28
07630243628094BRILLIANT EverGlow60019708600197082026-04-28
07630243628100BRILLIANT EverGlow60019709600197092026-04-28
07630243628117BRILLIANT EverGlow60019710600197102026-04-28
07630243628124BRILLIANT EverGlow60019716600197162026-04-28
07630243628131BRILLIANT EverGlow60019717600197172026-04-28
07630243628148BRILLIANT EverGlow60019718600197182026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887919227335Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
00887919317036Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029468Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029499Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029529Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029550Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029581Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029611Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029642Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029673Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029703Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029734Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029765Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029796Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029826Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029857Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029888Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029918Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029949Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029970Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
ESUN379P3140215Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2025-04-29
ESUN801C2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2025-04-29
ESUN801F3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801F3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801F3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801LC3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23