FDA.report

EDENTA

Primary DI
E3121104037101
Brand
EDENTA
Company
EDENTA ETABLISSEMENT
Model
1.104.037
Device description
Steel bur
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
EJLBUR, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E31211040371PrimaryHIBCC0
E3121104037101Unit of UseHIBCC0

GMDN Terms

TermDefinition
Steel dental bur, reusableA rotary cutting device made from high-grade carbon steel with the working end typically formed with cutting planes, e.g., spiralled flutes, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials intended for use in the fabrication of dental devices. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
448002915
Device count
5
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
00810126508270Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508294Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508300Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508317Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
00810126508324Sabur by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEJL2026-03-11
07908738731940DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730585DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730592DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730608DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730615DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730622DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730639DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730646DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730653DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730660DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730677DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730684DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730691DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730707DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730714DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730721DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730738DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730745DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730752DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730769DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730776DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730783DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730790DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730806DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10
07908738730813DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEJL2026-03-10