FDA.reportPublic FDA data

FG Dental Burs

Primary DI
07290119312214
Brand
FG Dental Burs
Company
BIOLINE DENTAL IMPLANT SYSTEMS LTD
Model
877/012
Catalog number
BIO-288/012
Published
2025-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
07290119312214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290119312214072901193122147290119312214

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
532209134
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290119312917Cylindrical Dental Implant CDI3.3mm diameter x 10mm lengthBIO-G33102026-05-18
07290119312924Cylindrical Dental Implant CDI3.3mm diameter x 11.5mm lengthBIO-G33112026-05-18
07290119312931Cylindrical Dental Implant CDI3.3mm diameter x 13mm lengthBIO-G33132026-05-18
07290119312948Cylindrical Dental Implant CDI3.3mm diameter x 16mm lengthBIO-G33162026-05-18
07290119312955Cylindrical Dental Implant CDI3.75mm diameter x 8mm lengthBIO-G37082026-05-18
07290119312962Cylindrical Dental Implant CDI3.75mm diameter x 10mm lengthBIO-G37102026-05-18
07290119312979Cylindrical Dental Implant CDI3.75mm diameter x 11.5mm lengthBIO-G37112026-05-18
07290119312986Cylindrical Dental Implant CDI3.75mm diameter x 13mm lengthBIO-G37132026-05-18
07290119312993Cylindrical Dental Implant CDI3.75mm diameter x 16mm lengthBIO-G37162026-05-18
07290119313006Cylindrical Dental Implant CDI4.2mm diameter x 8mm lengthBIO-G42082026-05-18
07290119313013Cylindrical Dental Implant CDI4.2mm diameter x 10mm lengthBIO-G42102026-05-18
07290119313020Cylindrical Dental Implant CDI4.2mm diameter x 11.5mm lengthBIO-G42112026-05-18
07290119313037Cylindrical Dental Implant CDI4.2mm diameter x 13mm lengthBIO-G42132026-05-18
07290119313044Cylindrical Dental Implant CDI4.2mm diameter x 16mm lengthBIO-G42162026-05-18
07290119313051Cylindrical Dental Implant CDI5mm diameter x 8mm lengthBIO-G50082026-05-18
07290119313068Cylindrical Dental Implant CDI5mm diameter x 10mm lengthBIO-G50102026-05-18
07290119313075Cylindrical Dental Implant CDI5mm diameter x 11.5mm lengthBIO-G50112026-05-18
07290119313082Cylindrical Dental Implant CDI5mm diameter x 13mm lengthBIO-G50132026-05-18
07290119313099Cylindrical Dental Implant CDI5mm diameter x 16mm lengthBIO-G50162026-05-18
07290119313105Cylindrical Dental Implant CDI6mm diameter x 8mm lengthBIO-G60082026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
ESUN801LC3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801LC3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801LC3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801SC3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801UF3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801UF3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801UF3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140215Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801VF3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23