FDA.reportPublic FDA data

DENFINITY

Primary DI
07908738728711
Brand
DENFINITY
Company
3R - INDUSTRIA E COMERCIO EIRELI
Model
41.098.4
Catalog number
41.098.4
Device description
FG Carbide Burs 001.014 Spherical 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

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
07908738728711PrimaryGS10
07908738730592Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908738728711079087387287117908738728711
07908738730592079087387305927908738730592

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
907197222
Device count
10
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
08404535036985Brasseler USAPeter Brasseler Holdings, LLCEJL2026-10-01
00810194409387AiraAIRA, LLCEJL2026-08-25
00810194409431AiraAIRA, LLCEJL2026-08-25
00810194409448AiraAIRA, LLCEJL2026-08-25
00810194409462AiraAIRA, LLCEJL2026-08-25
00810194409486AiraAIRA, LLCEJL2026-08-25
00810194409523AiraAIRA, LLCEJL2026-08-25
00810194409547AiraAIRA, LLCEJL2026-08-25
00810194409554AiraAIRA, LLCEJL2026-08-25
00810194409585AiraAIRA, LLCEJL2026-08-25
00810194409592AiraAIRA, LLCEJL2026-08-25
00810194409608AiraAIRA, LLCEJL2026-08-25
00810194409622AiraAIRA, LLCEJL2026-08-25
00810194409646AiraAIRA, LLCEJL2026-08-25
00810194409776AiraAIRA, LLCEJL2026-08-25
00810194409837AiraAIRA, LLCEJL2026-08-25
00810194409912AiraAIRA, LLCEJL2026-08-25
00810194409943AiraAIRA, LLCEJL2026-08-25
00810194409950AiraAIRA, LLCEJL2026-08-25
00810194409981AiraAIRA, LLCEJL2026-08-25
00810226100022AiraAIRA, LLCEJL2026-08-25
00810226100060AiraAIRA, LLCEJL2026-08-25
00810226100138AiraAIRA, LLCEJL2026-08-25
00810226100213AiraAIRA, LLCEJL2026-08-25
00810226100268AiraAIRA, LLCEJL2026-08-25
00810226100275AiraAIRA, LLCEJL2026-08-25
00810226100572AiraAIRA, LLCEJL2026-08-25
00810226100985AiraAIRA, LLCEJL2026-08-25
00810226101043AiraAIRA, LLCEJL2026-08-25
00810226101050AiraAIRA, LLCEJL2026-08-25