FDA.report

DENFINITY

Primary DI
07908738730912
Brand
DENFINITY
Company
3R - INDUSTRIA E COMERCIO EIRELI
Model
41.098.170L
Catalog number
41.098.170L
Device description
FG Carbide Burs 171.010 Conical Flat Tip PK/25
Published
2026-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
07908738729039PrimaryGS10
07908738730912Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07908738729039079087387290397908738729039
07908738730912079087387309127908738730912

GMDN Terms

TermDefinition
Carbide dental bur, reusableA rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
907197222
Device count
10
DM exempt
false
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
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07908738730066DENFINITY10.305.10210.305.1022026-03-13
07908738730103DENFINITY10.609.03010.609.0302026-03-13
07908738730110DENFINITY10.609.03110.609.0312026-03-13
07908738730127DENFINITY10.609.02810.609.0282026-03-13
07908738730134DENFINITY10.609.02910.609.0292026-03-13
07908738730141DENFINITY10.204.11410.204.1142026-03-13
07908738730158DENFINITY10.204.11510.204.1152026-03-13
07908738730165DENFINITY10.204.11310.204.1132026-03-13
07908738730172DENFINITY10.203.11410.203.1142026-03-13
07908738730189DENFINITY10.203.11510.203.1152026-03-13
07908738730196DENFINITY10.203.11310.203.1132026-03-13
07908738730202DENFINITY10.202.11410.202.1142026-03-13
07908738730219DENFINITY10.202.11510.202.1152026-03-13
07908738730226DENFINITY10.202.11310.202.1132026-03-13
07908738730233DENFINITY10.218.00910.218.0092026-03-13
07908738730240DENFINITY10.218.01010.218.0102026-03-13
07908738730257DENFINITY10.207.20410.207.2042026-03-13
07908738730264DENFINITY10.207.20510.207.2052026-03-13
07908738730271DENFINITY10.207.30610.207.3062026-03-13
07908738730288DENFINITY10.207.30710.207.3072026-03-13

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