FDA.reportPublic FDA data

EDENTA

Primary DI
E312862104014101
Brand
EDENTA
Company
EDENTA ETABLISSEMENT
Model
862.104.014
Device description
Diamond HP
Published
2022-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
E3128621040141PrimaryHIBCC0
E312862104014101Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Diamond dental laboratory burA 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 laboratory handpiece that provides the rotation and that is intended for dental laboratory use only to cut hard structures, e.g., hard materials, plastics, porcelains and similar materials, during the fabrication of dental restorations. The diamond coating may be bonded to the different shaped bur heads by, e.g., electroplating, sintering, or moulded in various shapes with a rubber binding material. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
448002915
Device count
3
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E3123661040121EDENTA366.104.0122022-02-03
E3123661040161EDENTA366.104.0162022-02-03
E3123681040231EDENTA368.104.023M368-023HP2022-02-03
E3123901040161EDENTA390.104.0162022-02-03
E3124896A1040801EDENTA4896A.104.0802022-02-03
E31253691040701EDENTA5369.104.0702022-02-03
E31258301040701EDENTA5830.104.0702022-02-03
E31258361040601EDENTA5836.104.0602022-02-03
E3125848L1040231EDENTA5848L.104.0232022-02-03
E31258561040231EDENTA5856.104.0232022-02-03
E31258561040401EDENTA5856.104.0402022-02-03
E31258601040601EDENTA5860.104.0602022-02-03
E31258621040601EDENTA5862.104.0602022-02-03
E31258931040471EDENTA5893.104.0472022-02-03
E31258931040601EDENTA5893.104.0602022-02-03
E31258961040801EDENTA5896.104.0802022-02-03
E31268011040351EDENTA6801.104.0352022-02-03
E31268361040551EDENTA6836.104.0552022-02-03
E31268411040371EDENTA6841.104.0372022-02-03
E3126842KR1040231EDENTA6842KR.104.0232022-02-03

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