FDA.report

DENFINITY

Primary DI
07908738728643
Brand
DENFINITY
Company
3R - INDUSTRIA E COMERCIO EIRELI
Model
10.155.3216C
Catalog number
10.155.3216C
Device description
FG Diamond Burs 878.012C Coarse Torpedo Cylindrical STERILE PK/25
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
EJLBur, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07908738728056PrimaryGS10
07908738728643Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07908738728056079087387280567908738728056
07908738728643079087387286437908738728643

GMDN Terms

TermDefinition
Diamond dental bur, reusableA rotary cutting device made of high-grade steel with the working end coated with particles of diamond, 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
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
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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