FDA.report

EDENTA

Primary DI
E312AC44100101
Brand
EDENTA
Company
EDENTA ETABLISSEMENT
Model
AC44-100
Device description
Acrypol green - tip
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
EJQWHEEL, POLISHING AGENT

Product Code Classifications

CodeDeviceSpecialtyClass
EJQWheel, Polishing AgentDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E312AC441001PrimaryHIBCC0
E312AC44100101Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dental abrasive point, reusableA rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
448002915
Device count
100
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
false

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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07630243636075KENDADent4You AGEJQ2025-09-17
07630243636082KENDADent4You AGEJQ2025-09-17
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07630243637379KENDADent4You AGEJQ2025-09-17
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07630243636730KENDADent4You AGEJQ2025-09-17