FDA.reportPublic FDA data

Steel burs cav. cyl. square

Primary DI
J003D0034250014001
Brand
Steel burs cav. cyl. square
Company
MAILLEFER INSTRUMENTS HOLDING Sàrl
Model
D003425001400
Catalog number
D003425001400
Device description
STEEL B.CYL.SQUARE 28MM RA 014
Published
2022-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EJLBUR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J003D0034250014001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Steel dental bur, reusableA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, 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, Specify00N/A

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480538495
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
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J0030525020Z1Gutta Percha Points ISO0525020Z0525020Z2026-08-26
J0030525025Z1Gutta Percha Points ISO0525025Z0525025Z2026-08-26
J0030525030Z1Gutta Percha Points ISO0525030Z0525030Z2026-08-26
J0030525035Z1Gutta Percha points0525035Z0525035Z2026-08-26
J0030525040Z1Gutta Percha points0525040Z0525040Z2026-08-26
J0030525045Z1Gutta Percha points0525045Z0525045Z2026-08-26
J0030525050Z1Gutta Percha points0525050Z0525050Z2026-08-26
J0030525055Z1Gutta Percha points0525055Z0525055Z2026-08-26
J0030525060Z1Gutta Percha points0525060Z0525060Z2026-08-26
J0030525160Z1Gutta Percha points0525160Z0525160Z2026-08-26
J0030525165Z1Gutta Percha Points GP0525165Z0525165Z2026-08-26
J0030530F1Gutta Percha Points GP0530F0530F2026-08-26
J0030530FF1Gutta Percha Points GP0530FF0530FF2026-08-26
J0030530FFZ1Gutta Percha Points GP0530FFZ0530FFZ2026-08-26
J0030530FM1Gutta Percha Points GP0530FM0530FM2026-08-26
J0030530FMZ1Gutta Percha Points GP0530FMZ0530FMZ2026-08-26
J0030530FZ1Gutta Percha Points GP0530FZ0530FZ2026-08-26
J0030530L1Gutta Percha Points GP0530L0530L2026-08-26
J0030530M1Gutta Percha Points GP0530M0530M2026-08-26
J0030530MF1Gutta Percha Points GP0530MF0530MF2026-08-26

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