FDA.report

FG Dental Burs

Primary DI
07290119311330
Brand
FG Dental Burs
Company
BIOLINE DENTAL IMPLANT SYSTEMS LTD
Model
886/014
Catalog number
BIO-131/014
Published
2025-03-05
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
DZPInstrument, Diamond, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07290119311330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07290119311330072901193113307290119311330

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
532209134
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
07290119310609Driver Hex 1.25mm7.1mm Diameter x 18.2mm LengthBIO-X12072025-03-21
07290119310616Driver Hex 1.25mm7.1mm Diameter x 21.2mm LengthBIO-X12102025-03-21
07290119310623Driver Hex 1.25mm7.1mm Diameter x 24.2mm LengthBIO-X12152025-03-21
07290119310630Driver Hex 2.42mm8mm Diameter x 17.2mm LengthBIO-X24072025-03-21
07290119310647Driver Hex 2.42mm8mm Diameter x 20.2mm LengthBIO-X24102025-03-21
07290119310654Driver Hex 2.42mm8mm Diameter x 25.2mm LengthBIO-X24152025-03-21
07290119310661Slim Hex Driver 2.1mm8mm Diameter x 15mm LengthBIO-X28072025-03-21
07290119310678Slim Hex Driver 2.1mm8mm Diameter x 18mm LengthBIO-X28102025-03-21
07290119310685Slim Hex Driver 2.1mm8mm Diameter x 23mm LengthBIO-X28152025-03-21
07290119310692Driver Hex 1.25mm short8mm Diameter x 23.6mm LengthBIO-X10062025-03-21
07290119310708Driver Hex 1.25mm long8mm Diameter x 28.6mm LengthBIO-X10072025-03-21
07290119310715Scan Body4.2mm Diameter x 9mm LengthBIO-SBR2025-03-21
07290119310722Digital Analog4.5mm Diameter x 12mm LengthBIO-DAR2025-03-21
07290119310739Scan Body for Slim Connection4.2mm Diameter x 9mm LengthBIO-SBS2025-03-21
07290119310746Digital Analog for Slim Connection4.5mm Diameter x 12mm LengthBIO-DAS2025-03-21
07290119310753Scan Body for Conical Connection4.2mm Diameter x 9.7mm LengthCSD-SBR2025-03-21
07290119310579Depth Probe1.7mm Diameter x 105.3mm LengthBIO-X10252025-03-20
07290119310586Depth Probe2.3mm Diameter x 49.5mm LengthBIO-PTR012025-03-20
07290119310593Depth Probe3.2mm Diameter x 79.5mm LengthBIO-ZPR012025-03-20
07290119310555Torque Ratchet98.4mm LengthBIO-X10212025-03-19

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