AVALON BIOMED

GUDID 06975718059500

Shenzhen Denco Medical Co., Ltd

Manual endodontic file/rasp, single-use

• Primary Device ID: 06975718059500
• NIH Device Record Key: 5fef6f20-6435-4bac-ae25-b85d4270b5ee
• Commercial Distribution Discontinuation: 2030-06-22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVALON BIOMED
• Version Model Number: SlimShaper sterile files 25mm ZS1-ZS3 (6 units)
• Company DUNS: 543035008
• Company Name: Shenzhen Denco Medical Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975718059500 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-01
• Device Publish Date: 2025-06-23

On-Brand Devices [AVALON BIOMED]

• 06975718050620: ApicalShaper sterile 25mm Z35/03
• 06975718050606: ApicalShaper sterile 31mm Z30/03
• 06975718050590: ApicalShaper sterile 25mm Z30/03
• 06975718050583: ApicalShaper sterile 21mm Z30/03
• 06975718050521: Excalibur sterile 25mm E45
• 06975718050514: Excalibur sterile 21mm E45
• 06975718050491: Excalibur sterile 25mm E35
• 06975718050484: Excalibur sterile 21mm E35
• 06975718050453: Excalibur sterile 21mm E25
• 06975718050361: SlimShaper sterie 25mm ZS3
• 06975718050354: SlimShaper sterie 25mm ZS2
• 06975718050347: SlimShaper sterie 25mm ZS1
• 06975718050323: SlimShaper sterile 21mm ZS3
• 06975718050316: SlimShaper sterile 21mm ZS2
• 06975718050309: SlimShaper sterile 21mm ZS1
• 06975718050293: SlimShaper sterile 21mm ZS1-ZS3
• 06975718050149: BlueShaper sterile 25mm Z1
• 06975718050057: BlueShaper sterile 21mm ZX-Z5
• 06975718050040: BlueShaper sterile 19mm ZX
• 06975718059821: BlueShaper PRO sterile files 16mm ZXS (6 units)
• 06975718059814: Z-Glider EVO sterile files 31mm
• 06975718059807: Z-Glider EVO sterile files 25mm
• 06975718059791: Z-Glider EVO sterile files 21mm
• 06975718059784: SlimShaper PRO sterile files 31mm ZS1-ZS3 (6 units
• 06975718059777: SlimShaper PRO sterile files 25mm ZS1-ZS3 (6 units
• 06975718059760: SlimShaper PRO sterile files 21mm ZS1-ZS3 (6 units
• 06975718059739: BlueShaper PRO sterile files 25mm ZX-Z5 (6 units)
• 06975718059722: BlueShaper PRO sterile files 21mm ZX-Z5 (6 units)
• 06975718059708: ApicalShaper sterile 25mm Z30-Z50 (4 units)
• 06975718059692: ApicalShaper sterile 21mm Z30-Z50 (4 units)
• 06975718059678: ApicalShaper sterile 25mm Z50/03 (6 units)
• 06975718059654: ApicalShaper sterile 25mm Z40/03 (6 units)
• 06975718059647: ApicalShaper sterile 25mm Z35/03 (6 units)
• 06975718059623: ApicalShaper sterile 25mm Z30/03 (6 units)
• 06975718059616: ApicalShaper sterile 21mm Z30/03 (6 units)
• 06975718059609: Excalibur sterile 25mm E20-E45 (4 units)
• 06975718059593: Excalibur sterile 21mm E20-E45 (4 units)
• 06975718059500: SlimShaper sterile files 25mm ZS1-ZS3 (6 units)
• 06975718059494: SlimShaper sterile files 21mm ZS1-ZS3 (6 units)
• 06975718059432: Z-Gauge Ruler
• 06975718059425: Endo-Block Ruler
• 06975718059418: BlueShaper sterile files 31mm Z4 (6 units)
• 06975718059395: BlueShaper sterile files 25mm Z6 (6 units)
• 06975718059340: BlueShaper sterile files 25mm Z1 (6 units)
• 06975718059333: BlueShaper sterile files 25mm ZX-Z5 (6 units)
• 06975718059296: BlueShaper sterile files 21mm ZX-Z5 (6 units)
• 06975718056295: Z-Glider EVO sterile files 25mm