FDA.reportPublic FDA data

EDENTA

Primary DI
E312183192040901
Brand
EDENTA
Company
EDENTA ETABLISSEMENT
Model
183.19.204.090
Catalog number
EP205-090
Device description
"Root canal reamers ""Peeso"""
Published
2022-02-03
Public version status
Update
Distribution status
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
E312183192040901PrimaryHIBCC0
E31218319204090101Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
448002915
Device count
6
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E3123661040121EDENTA366.104.0122022-02-03
E3123661040161EDENTA366.104.0162022-02-03
E3123681040231EDENTA368.104.023M368-023HP2022-02-03
E3123901040161EDENTA390.104.0162022-02-03
E3124896A1040801EDENTA4896A.104.0802022-02-03
E31253691040701EDENTA5369.104.0702022-02-03
E31258301040701EDENTA5830.104.0702022-02-03
E31258361040601EDENTA5836.104.0602022-02-03
E3125848L1040231EDENTA5848L.104.0232022-02-03
E31258561040231EDENTA5856.104.0232022-02-03
E31258561040401EDENTA5856.104.0402022-02-03
E31258601040601EDENTA5860.104.0602022-02-03
E31258621040601EDENTA5862.104.0602022-02-03
E31258931040471EDENTA5893.104.0472022-02-03
E31258931040601EDENTA5893.104.0602022-02-03
E31258961040801EDENTA5896.104.0802022-02-03
E31268011040351EDENTA6801.104.0352022-02-03
E31268361040551EDENTA6836.104.0552022-02-03
E31268411040371EDENTA6841.104.0372022-02-03
E3126842KR1040231EDENTA6842KR.104.0232022-02-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07290116154787Dental DrillsNORIS MEDICAL LTDDZA2026-07-09
07290116154794Diamond BurrsNORIS MEDICAL LTDDZA2026-07-09
088000702492151.2 Hex Angled Machine Screw DriverIzenimplant Co., Ltd.DZA2026-06-22
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06932195395071DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
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06932195395095DrillChengdu Besmile Medical Technology Co., Ltd.DZA2026-06-10
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