FDA.report

EDENTA

Primary DI
E312ST1035101
Brand
EDENTA
Company
EDENTA ETABLISSEMENT
Model
ST-10.35
Device description
ST-Reamer
Published
2022-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DZADRILL, DENTAL, INTRAORAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E312ST10351PrimaryHIBCC0
E312ST1035101Unit of UseHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
448002915
Device count
6
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
E3120001UM100101EDENTA0001UM-1002022-02-03
E3120001UM12101EDENTA0001UM-122022-02-03
E3120005UM100101EDENTA0005UM-1002022-02-03
E3120005UM12101EDENTA0005UM-122022-02-03
E3120023UM100101EDENTA0023UM-1002022-02-03
E3120023UM12101EDENTA0023UM-122022-02-03
E3120030RA100101EDENTA0030RA-1002022-02-03
E3120030RA12101EDENTA0030RA-122022-02-03
E3120031RA100101EDENTA0031RA-1002022-02-03
E3120031RA12101EDENTA0031RA-122022-02-03
E3120032RA100101EDENTA0032RA-1002022-02-03
E3120032RA12101EDENTA0032RA-122022-02-03
E3120033RA100101EDENTA0033RA-1002022-02-03
E3120033RA12101EDENTA0033RA-122022-02-03
E3120034RA100101EDENTA0034RA-1002022-02-03
E3120034RA12101EDENTA0034RA-122022-02-03
E3120035RA100101EDENTA0035RA-1002022-02-03
E3120035RA12101EDENTA0035RA-122022-02-03
E3120036RA100101EDENTA0036RA-1002022-02-03
E3120036RA12101EDENTA0036RA-122022-02-03

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