FDA.reportPublic FDA data

AVALON BIOMED

Primary DI
06942512500200
Brand
AVALON BIOMED
Company
Shenzhen Denco Medical Co., Ltd
Model
Excalibur PRO sterile 31mm E45 (6 units)
Published
2025-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
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
06942512500200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942512500200069425125002006942512500200

GMDN Terms#

Term, Definition table
TermDefinition
Manual endodontic file/rasp, single-useA hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. 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 an endodontic reamer. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543035008
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942512502266AVALON BIOMEDZ-Micro Opener 10.04 (3 units)ZMO12025-11-25
06942512509166AVALON BIOMEDZ-Micro Shaper 20 .02 (3 units)ZMS12025-11-25
06942512509173AVALON BIOMEDZ-Micro Shaper 25 .02 (3 units)ZMS22025-11-25
06942512509180AVALON BIOMEDZ-Micro Shaper 30 .02 (3 units)ZMS32025-11-25
06942512509197AVALON BIOMEDZ-Micro Shaper ASSORTED (3 units)ZMSA2025-11-25
06942512509203AVALON BIOMEDZ-Micro Opener 15.04 (3 units)ZMO22025-11-25
06942512509210AVALON BIOMEDZ-Micro Opener 20.04 (3 units)ZMO32025-11-25
06942512509227AVALON BIOMEDZ-Micro Opener ASSORTED (3 units)ZMOA2025-11-25
06942512507841AVALON BIOMEDAtacadores manuales Z-Plugger de Zarc (35/70)2025-10-11
06942512507858AVALON BIOMEDAtacadores manuales Z-Plugger de Zarc (40/80)2025-10-11
06942512507865AVALON BIOMEDAtacadores manuales Z-Plugger de Zarc (50/100)2025-10-11
06942512507872AVALON BIOMEDAtacadores manuales Z-Plugger de Zarc (60/120)2025-10-11
06942512507889AVALON BIOMEDAtacadores manuales Z-Plugger de Zarc (Surtido)2025-10-11
06942512500637AVALON BIOMEDBlueShaper sterile files 19mm ZX (6 units)2025-07-21
06942512500644AVALON BIOMEDBlueShaper sterile files 21mm Z2 (6 units)2025-07-21
06942512500651AVALON BIOMEDBlueShaper sterile files 21mm Z5 (6 units)2025-07-21
06942512500668AVALON BIOMEDBlueShaper sterile files 21mm Z6 (6 units)2025-07-21
06942512500675AVALON BIOMEDBlueShaper sterile files 21mm Z7 (6 units)2025-07-21
06942512500682AVALON BIOMEDBlueShaper sterile files 21mm Z1-Z4 (4 units)2025-07-21
06942512500699AVALON BIOMEDBlueShaper sterile files 25mm Z7 (6 units)2025-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810213812679EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812686EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812693EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812709EdgeEndoHSG-S Corp.EKS2026-06-24