FDA.reportPublic FDA data

REAMERS (Nickel-Titanium)

Primary DI
08806383532266
Brand
REAMERS (Nickel-Titanium)
Company
DiaDent Group International
Model
25m/m 20
Catalog number
NT501-204
Device description
REAMERS are mainly used to the preparation for various of dental pulp inflammation and dead dental pulp root canal treatment.
Published
2020-06-15
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
EKSFile, Pulp Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806383532266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806383532266088063835322668806383532266

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
687789453
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806383540995DIAFILA3 Refill PackageA2009-20032026-10-07
08806383541008DIAFILA3.5 Refill PackageA2009-20042026-10-07
08806383541015DIAFILA4 Refill PackageA2009-20052026-10-07
08806383541022DIAFILB1 Refill PackageA2009-20062026-10-07
08806383541039DIAFILB2 Refill PackageA2009-20072026-10-07
08806383541046DIAFILB3 Refill PackageA2009-20082026-10-07
08806383541053DIAFILC2 Refill PackageA2009-20092026-10-07
08806383541060DIAFILC3 Refill PackageA2009-20102026-10-07
08806383541091DIAFILCL Refill PackageA2009-20132026-10-07
08806383541107DIAFILB4 Refill PackageA2009-20142026-10-07
08806383541114DIAFILC1 Refill PackageA2009-20152026-10-07
08806383541121DIAFILC4 Refill PackageA2009-20162026-10-07
08806383541138DIAFILD1 Refill PackageA2009-20172026-10-07
08806383541145DIAFILD2 Refill PackageA2009-20182026-10-07
08806383541152DIAFILD3 Refill PackageA2009-20192026-10-07
08806383541169DIAFILD4 Refill PackageA2009-20202026-10-07
08806383541176DIAFILCapsule Type A1A2009-40012026-10-07
08806383541183DIAFILCapsule Type A2A2009-40022026-10-07
08806383541190DIAFILCapsule Type A3A2009-40032026-10-07
08806383541206DIAFILCapsule Type A3.5A2009-40042026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640452460194Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460200Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460217Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460224Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460231Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460248Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460255Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460262Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460279Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460286Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460293Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460309Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460316Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460323Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460330Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460347Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460354Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460361Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460378Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460385Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460392Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460408Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460415Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460422Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460439Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460446Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460453Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460460Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460477Edge EvolveFKG Dentaire SàrlEKS2026-10-27
07640452460484Edge EvolveFKG Dentaire SàrlEKS2026-10-27