FDA.report

DENFINITY

Primary DI
07908738730288
Brand
DENFINITY
Company
3R - INDUSTRIA E COMERCIO EIRELI
Model
10.207.307
Catalog number
10.207.307
Device description
Finishing & Polishing Composite Diamond Ceramic Spiral 543 Ra Medium 3 /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
EHLPoint, Abrasive

Product Code Classifications

CodeDeviceSpecialtyClass
EHLPoint, AbrasiveDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07908738730288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07908738730288079087387302887908738730288

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
Moist Heat or Steam Sterilization

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
true

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
07908738730295DENFINITY10.207.30810.207.3082026-03-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08404535024579Brasseler USAPeter Brasseler Holdings, LLCEHL2026-03-17
08404535024609Brasseler USAPeter Brasseler Holdings, LLCEHL2026-03-17
08404535024630Brasseler USAPeter Brasseler Holdings, LLCEHL2026-03-17
08404535024661Brasseler USAPeter Brasseler Holdings, LLCEHL2026-03-17
00840479201481RENEW SYSTEM POINTSRELIANCE ORTHODONTIC PRODUCTS INCEHL2026-03-13
07908738730141DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730158DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730165DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730172DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730189DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730196DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730202DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730219DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730226DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730233DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730240DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730257DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730264DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730271DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730295DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730479DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730486DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730493DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730523DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730530DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738730547DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
07908738737775DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHL2026-03-13
00840479202495RENEW SYSTEM POINTSRELIANCE ORTHODONTIC PRODUCTS INCEHL2026-03-11
00840479202501RENEW SYSTEM POINTSRELIANCE ORTHODONTIC PRODUCTS INCEHL2026-03-11
00840479202518RENEW SYSTEM POINTSRELIANCE ORTHODONTIC PRODUCTS INCEHL2026-03-11