AVALON BIOMED

Primary DI
06975718051955
Brand
AVALON BIOMED
Company
Shenzhen Denco Medical Co., Ltd
Model
NanoShaper Assorted 21 ZN1-ZN3 (3 units)
Published
2025-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
06975718051955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975718051955069757180519556975718051955

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
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
06942512500705AVALON BIOMEDBlueShaper sterile files 25mm Z1-Z4 (4 units)2025-07-21
06942512500712AVALON BIOMEDBlueShaper sterile files 31mm ZX-Z5 (6 units)2025-07-21
06942512500729AVALON BIOMEDBlueShaper sterile files 31mm Z1 (6 units)2025-07-21
06942512500736AVALON BIOMEDBlueShaper sterile files 31mm Z2 (6 units)2025-07-21
06942512500743AVALON BIOMEDBlueShaper sterile files 31mm Z5 (6 units)2025-07-21

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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80810213810053EdgeEndoHSG-S Corp.EKS2026-03-23
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80810213810077EdgeEndoHSG-S Corp.EKS2026-03-23
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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
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80810213810275EdgeEndoHSG-S Corp.EKS2026-03-23