FDA.reportPublic FDA data

Aurum (Blue T3 Refill 31mm)

Primary DI
08806387850465
Brand
Aurum (Blue T3 Refill 31mm)
Company
Meta Biomed Co., Ltd.
Model
5046
Device description
The product is suitable for root canal therapy for root canal cleaning and shaping. Can be reused.
Published
2022-09-24
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
08806387850465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806387850465088063878504658806387850465

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, reusableA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
688322841
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806387894049Metacem Set94042018-08-30
08806387894803Metapex Plus 0.894802021-04-16
08806387809388MG 04-15/40 LM09382025-08-26
08806387809395MG 06-15/40 LM09392025-08-26
08806387892090Meta Etchant92092016-09-19
08806387814603MX 02-1514602025-08-26
08806387814610MX 02-2014612025-08-26
08806387814627MX 02-2514622025-08-26
08806387814634MX 02-3014632025-08-26
08806387814641MX 02-3514642025-08-26
08806387814658MX 02-4014652025-08-26
08806387814665MX 04-1514662025-08-26
08806387814672MX 04-2014672025-08-26
08806387814689MX 04-2514682025-08-26
08806387814696MX 04-3014692025-08-26
08806387814702MX 04-3514702025-08-26
08806387814719MX 04-4014712025-08-26
08806387814726MX 06-1514722025-08-26
08806387814733MX 06-2014732025-08-26
08806387814740MX 06-2514742025-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941877830076EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-05-26
06941877830083EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-05-26
80810213810008EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810015EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810022EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810039EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810046EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810053EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810060EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810077EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810084EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810091EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810107EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810114EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810121EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810138EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810145EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810152EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810169EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810176EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810183EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810190EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810206EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810213EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810220EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810237EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810244EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810251EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810268EdgeEndoHSG-S Corp.EKS2026-03-23
80810213810275EdgeEndoHSG-S Corp.EKS2026-03-23