FDA.reportPublic FDA data

LARGO® Peeso Reamer

Primary DI
J003A0009230006001
Brand
LARGO® Peeso Reamer
Company
MAILLEFER INSTRUMENTS HOLDING Sàrl
Model
A000923000600
Catalog number
A000923000600
Device description
Endodontic Instrument
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
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J003A0009230006001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic enlarger, reusableA manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. 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
Primary DIBrandModelCatalogPublished
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887919581727DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581741DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
00887919581765DENTFLEX FIBER POSTPeter Brasseler Holdings, LLCDZA2026-09-25
08800394921293Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921309Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
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08800394921347Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921354Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
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08800394921415Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
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08800394921446Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921453Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921460Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
08800394921477Neobiotech Implant SystemNeobiotech. co., ltdDZA2026-09-22
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08059224218014INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
06942686761223DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761230DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761247DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21
06942686761254DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-08-21