FDA.reportPublic FDA data

Diamond Instruments

Primary DI
E527041573DA1
Brand
Diamond Instruments
Company
Gebr. Brasseler GmbH & Co. KG
Model
E802M.314.018.DA
Catalog number
E802M.314.018
Published
2023-02-01
Public version status
Update
Distribution status
Not 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
E527041573DA2PackageHIBCC10Not in Commercial Distribution
E527041573DA1PrimaryHIBCC0
E527041573DA8Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
317409001
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
E527041508DA1Diamond InstrumentsE862C.314.016.DAE862C.314.0162023-02-01
E527041514DA1Diamond InstrumentsE878C.314.012.DAE878C.314.0122023-02-01
E527041522DA1Diamond InstrumentsE881C.314.014.DAE881C.314.0142023-02-01
E527041540DA1Diamond InstrumentsE801M.314.008.DAE801M.314.0082023-02-01
E527041541DA1Diamond InstrumentsE850F.314.018.DAE850F.314.0182023-02-01
E527041542DA1Diamond InstrumentsE850M.314.018.DAE850M.314.0182023-02-01
E527041543DA1Diamond InstrumentsE858F.314.014.DAE858F.314.0142023-02-01
E527041544DA1Diamond InstrumentsE859F.314.016.DAE859F.314.0162023-02-01
E527041545DA1Diamond InstrumentsE862F.314.016.DAE862F.314.0162023-02-01
E527041546DA1Diamond InstrumentsE862M.314.014.DAE862M.314.0142023-02-01
E527041550DA1Diamond InstrumentsE859EF.314.016.DAE859EF.314.0162023-02-01
E527041557DA1Diamond InstrumentsE368M.314.018.DAE368M.314.0182023-02-01
E527041565DA1Diamond InstrumentsE801M.314.010.DAE801M.314.0102023-02-01
E527041566DA1Diamond InstrumentsE801M.314.012.DAE801M.314.0122023-02-01
E527041567DA1Diamond InstrumentsE801M.314.014.DAE801M.314.0142023-02-01
E527041571DA1Diamond InstrumentsE802M.314.014.DAE802M.314.0142023-02-01
E527041576DA1Diamond InstrumentsE805M.314.012.DAE805M.314.0122023-02-01
E527041577DA1Diamond InstrumentsE805M.314.014.DAE805M.314.0142023-02-01
E527041578DA1Diamond InstrumentsE805M.314.016.DAE805M.314.0162023-02-01
E527041580DA1Diamond InstrumentsE806M.314.014.DAE806M.314.0142023-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E0HM51008203140041n/aHager & Meisinger Gesellschaft mit beschränkter HaftungDZP2026-10-23
E0HM510820C3140021n/aHager & Meisinger Gesellschaft mit beschränkter HaftungDZP2026-10-23
E0HM510820C3140031n/aHager & Meisinger Gesellschaft mit beschränkter HaftungDZP2026-10-23
E0HM510820G3140051n/aHager & Meisinger Gesellschaft mit beschränkter HaftungDZP2026-10-23
08404535025309Brasseler USAPeter Brasseler Holdings, LLCDZP2026-04-29
E527049101DA1ECOLINE Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-08-09
E226015339A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226015342A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226015349A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226015737G11KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226017272G11KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226017276AU1KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226017279A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226017290A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226017830A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226018303G11KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226018636A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226018705A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226019880A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226023159A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226030503A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226030513A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226030520A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226030527A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226030538A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226030540A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226030544A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226033010A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226033870A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01
E226033871A21KOMET Dental Diamond InstrumentsGebr. Brasseler GmbH & Co. KGDZP2023-02-01