FDA.reportPublic FDA data

DENFINITY

Primary DI
07908738727127
Brand
DENFINITY
Company
3R - INDUSTRIA E COMERCIO EIRELI
Model
10.154.1016VC
Catalog number
10.154.1016VC
Device description
FG Diamond Burs 801.018XC Extra Coarse Spherical PK/5
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07908738727127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908738727127079087387271277908738727127

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
907197222
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Donation ID number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
ESUNC1623160165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2025-04-29
07630049901384C141 Allport bone cutterDiaswiss SAEJL2023-10-02
07630049901612DIA-ZDiaswiss SAEJL2023-10-02
07630049902077Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951051Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951075Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951532Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049951556FG Diacarb finishing bur HCDiaswiss SAEJL2023-10-02
07630049951921C141 Allport bone cutterDiaswiss SAEJL2023-10-02
07630049951983Carbide bur Diacarb RA HCDiaswiss SAEJL2023-10-02
07630049952003Carbide finishing bur Diacarb RADiaswiss SAEJL2023-10-02
07630049952041FG Diacarb carbide crown cutterDiaswiss SAEJL2023-10-02
07630049952065Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049952089FG Diacarb finishing burDiaswiss SAEJL2023-10-02
07630049952164FG Diacarb finishing burDiaswiss SAEJL2023-10-02
07630049952188FG Diacarb finishing burDiaswiss SAEJL2023-10-02
ESUNC283K3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-25
ESUNC33L3140105Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC33L3140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040275Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCTR323140125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040125Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC463140145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07