FDA.report

DENFINITY

Primary DI
07908738730127
Brand
DENFINITY
Company
3R - INDUSTRIA E COMERCIO EIRELI
Model
10.609.028
Catalog number
10.609.028
Device description
Impregnated Brush Ra Cup Type Alumina 5/Pk
Published
2026-03-13
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
EHJDisk, Abrasive

Product Code Classifications

CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07908738730127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07908738730127079087387301277908738730127

GMDN Terms

TermDefinition
Dental polishing brushA rotational device, typically composed of a metal shaft with bristles containing silicium carbide material, that is used for the quick grinding and polishing of dental composite materials and hard dental tissues to produce a high shine. It is held in a dental handpiece, which rotates the brush at high speeds [e.g., 5000 revolutions per minute (rpm)]. It is suitable for interproximal areas and occlusal surfaces. This is a reusable device.

Sterilization Methods

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 DIBrandModelCatalogPublished
07908738730066DENFINITY10.305.10210.305.1022026-03-13
07908738730103DENFINITY10.609.03010.609.0302026-03-13
07908738730110DENFINITY10.609.03110.609.0312026-03-13
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
07908738730295DENFINITY10.207.30810.207.3082026-03-13

Other Devices Sharing Product Codes

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
07908738730134DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-13
07908738730073DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-10
07908738730080DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-10
07908738730097DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-10
D8120149280BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455440BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455480BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455520BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455560BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455600BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455640BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455680BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455720BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455761BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455801BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
00883205031501JiffyULTRADENT PRODUCTS, INC.EHJ2025-09-19
07615208472707OptraGlossIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20
07615208292824OptraGlossIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20
07615208471199Politip P / Politip FIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20
07615208471182Politip P / Politip FIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20
07615208471175Politip P / Politip FIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20
07615208471168Politip P / Politip FIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20
07615208471151Politip P / Politip FIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20
07615208469042Politip P / Politip FIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20