FDA.reportPublic FDA data

Avalon Biomed by Zarc BlueShaper PRO File 25mm (Z4)

Primary DI
00810118104169
Brand
Avalon Biomed by Zarc BlueShaper PRO File 25mm (Z4)
Company
NUSMILE, LTD.
Model
ZBS25ZPRO4
Device description
Blister of 6 units + petals
Published
2023-12-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
00810118104169PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810118104169008101181041698101181041690810118104169

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
832-540-5964plara@nusmile.com

Regulatory Flags#

DUNS number
185497372
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810118108082NuSmile BioCemBCVKXL2026-09-22
08809911118536NuSmile NuCemNCRSKI2026-04-08
08809911118543NuSmile NuCemNCRPKI2026-04-08
08809911118529NuSmile NuCemNUCEMSU2026-07-21
08809911118550NuSmile NuCemNUCEMSUI2026-07-21
00810118108075NuSmile NuCemSNUCEM2026-04-21
08809911118505NuSmile NuCemNCRSK2026-04-14
08809911118512NuSmile NuCemNCRPK2026-04-14
00810118107962NuSmile Bite Stick / Band SeaterBS-0012026-04-08
00810118107979NuSmile Heavy Band PusherBP-0022026-04-08
00810118107986NuSmile 3 Jaw PlierTJP-0032026-04-08
00810118107993NuSmile Bird Beak PlierBBP-0042026-04-08
00810118108006NuSmile Band / Crown Crimping PlierBCP-0052026-04-08
00810118108013NuSmile Heavy Curved ScissorsHCS-0062026-04-08
00810118108020NuSmile Posterior Band RemoverPBR-0072026-04-08
00810118108037NuSmile Tube Crimping PlierTCP-0082026-04-08
00810118108044NuSmile Contouring PlierCP-0092026-04-08
00810118108051NuSmile Hard Wire CutterHWC-0102026-04-08
00810118107948NuSmile NuCemNCRSKI2026-04-08
00810118107955NuSmile NuCemNCRPKI2026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850085821171K FileCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
00850085821188K FileCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
00850085821195K FileCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
00850085821201H FilesCREATIVE ENDODONTIC TECHNOLOGY LLCEKS2026-07-21
00810213812419EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812426EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812433EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812440EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812457EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812464EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812471EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812488EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812495EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812501EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812518EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812525EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812532EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812549EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812556EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812563EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812570EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812587EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812594EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812600EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812617EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812624EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812631EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812648EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812655EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812662EdgeEndoHSG-S Corp.EKS2026-06-24