FDA.reportPublic FDA data

EDENTA

Primary DI
E3124018HP6101
Brand
EDENTA
Company
EDENTA ETABLISSEMENT
Model
4018HP-6
Device description
Mooremandrell
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

Product Codes#

Code, Name table
CodeName
EJQWHEEL, POLISHING AGENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJQWheel, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E3124018HP61PrimaryHIBCC0
E3124018HP6101Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental laboratory mandrelA round shaft of substantial dimensions designed to be used in the dental laboratory to hold (locked into place) a rotating device, e.g., a grinding or polishing wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing; connectors and rotating endpieces may be included with the device. The mandrel will be placed into a laboratory dental handpiece or lathe that will rotate at high speed. This is a reusable device.

Sterilization Methods#

Method table
Method

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
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243641123KENDADent4You AGEJQ2025-09-17
07630243641130KENDADent4You AGEJQ2025-09-17
07630243641147KENDADent4You AGEJQ2025-09-17
07630243641154KENDADent4You AGEJQ2025-09-17
07630243641161KENDADent4You AGEJQ2025-09-17
07630243641178KENDADent4You AGEJQ2025-09-17
07630243641185KENDADent4You AGEJQ2025-09-17
07630243641192KENDADent4You AGEJQ2025-09-17
07630243641208KENDADent4You AGEJQ2025-09-17
07630243641215KENDADent4You AGEJQ2025-09-17
07630243641222KENDADent4You AGEJQ2025-09-17
07630243641239KENDADent4You AGEJQ2025-09-17
07630243641246KENDADent4You AGEJQ2025-09-17
07630243641253KENDADent4You AGEJQ2025-09-17
07630243641260KENDADent4You AGEJQ2025-09-17
07630243641277KENDADent4You AGEJQ2025-09-17
07630243641284KENDADent4You AGEJQ2025-09-17
07630243641291KENDADent4You AGEJQ2025-09-17
07630243641307KENDADent4You AGEJQ2025-09-17
07630243641314KENDADent4You AGEJQ2025-09-17
07630243641321KENDADent4You AGEJQ2025-09-17
07630243641338KENDADent4You AGEJQ2025-09-17
07630243641345KENDADent4You AGEJQ2025-09-17
07630243641352KENDADent4You AGEJQ2025-09-17
07630243641369KENDADent4You AGEJQ2025-09-17
07630243641376KENDADent4You AGEJQ2025-09-17
07630243641383KENDADent4You AGEJQ2025-09-17
07630243641390KENDADent4You AGEJQ2025-09-17
07630243641420KENDADent4You AGEJQ2025-09-17
07630243641437KENDADent4You AGEJQ2025-09-17