FDA.reportPublic FDA data

DENFINITY

Primary DI
07908738730097
Brand
DENFINITY
Company
3R - INDUSTRIA E COMERCIO EIRELI
Model
10.810.023
Catalog number
10.810.023
Device description
Finishing & Polishing Discs Single Face MaxSoft 48 /Pk + 1 Mandrel
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

Product Codes#

Code, Name table
CodeName
EHJDisk, Abrasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07908738730097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908738730097079087387300977908738730097

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive disk, reusableA dental instrument consisting of a circular flat or slightly conical sheet carrying or containing an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
907197222
Device count
1
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
false

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
00348783011913Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-26
00348783011937Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-26
00348783011951Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-26
07908738730066DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-13
07908738730103DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-13
07908738730110DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-13
07908738730127DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-13
07908738730134DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-13
07908738730073DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-10
07908738730080DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-10
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