FDA.report

DENFINITY

Primary DI
07908738730516
Brand
DENFINITY
Company
3R - INDUSTRIA E COMERCIO EIRELI
Model
10.319.007
Catalog number
10.319.007
Device description
Stainless Steel Prophylaxis Strips Micro Blades 4.0mm 12 /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
EHMStrip, Polishing Agent

Product Code Classifications

CodeDeviceSpecialtyClass
EHMStrip, Polishing AgentDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07908738730516PrimaryGS10

GMDN Terms

TermDefinition
Dental abrasive strip, single-useA manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use 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
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 DIBrandCompanyProduct codePublished
07908738730509DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730554DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730561DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730578DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-13
07908738730301DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730318DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730325DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730332DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730356DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730363DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730370DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730387DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730394DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730400DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730417DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730424DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730431DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730448DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730455DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
07908738730462DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHM2026-03-10
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10190707192331Galaxy™Ortho Organizers, Inc.EHM2025-10-23
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