FDA.report

EDENTA

Primary DI
E312341HP1
Brand
EDENTA
Company
EDENTA ETABLISSEMENT
Model
341HP
Device description
CeraGloss HP - green
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
E312341HP1PrimaryHIBCC0

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
1
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
07630243636051KENDADent4You AGEJQ2025-09-17
07630243636075KENDADent4You AGEJQ2025-09-17
07630243636082KENDADent4You AGEJQ2025-09-17
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07630243636112KENDADent4You AGEJQ2025-09-17
07630243636099KENDADent4You AGEJQ2025-09-17
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07630243636068KENDADent4You AGEJQ2025-09-17
07630243636228KENDADent4You AGEJQ2025-09-17
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07630243636266KENDADent4You AGEJQ2025-09-17
07630243641727KENDADent4You AGEJQ2025-09-17
07630243637225KENDADent4You AGEJQ2025-09-17
07630243637232KENDADent4You AGEJQ2025-09-17
07630243637249KENDADent4You AGEJQ2025-09-17
07630243637256KENDADent4You AGEJQ2025-09-17
07630243637362KENDADent4You AGEJQ2025-09-17
07630243637379KENDADent4You AGEJQ2025-09-17
07630243637386KENDADent4You AGEJQ2025-09-17
07630243637393KENDADent4You AGEJQ2025-09-17
07630243642052KENDADent4You AGEJQ2025-09-17
07630243642069KENDADent4You AGEJQ2025-09-17
07630243636709KENDADent4You AGEJQ2025-09-17
07630243636716KENDADent4You AGEJQ2025-09-17
07630243636730KENDADent4You AGEJQ2025-09-17