Denco

GUDID 06970514910109

SHENZHEN DENCO MEDICAL CO., LTD

Manual endodontic file/rasp, single-use

• Primary Device ID: 06970514910109
• NIH Device Record Key: 4c451c93-3b2f-43b0-b43d-813bd9c92069
• Commercial Distribution Discontinuation: 2024-03-26
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Denco
• Version Model Number: 25mm C+ FILES #6-10
• 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: false
• 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	06970514910109 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

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

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

[06970514910109]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-29
• Device Publish Date: 2024-03-21

On-Brand Devices [Denco ]

• 06970514918181: 25mm PASTE CARRIERS #25-40
• 06970514914114: 21mm Barbed broaches #0-6
• 06970514912714: 21mm Barbed broaches #4
• 06970514912707: 21mm Barbed broaches #3
• 06970514912691: 21mm Barbed broaches #2
• 06970514912684: 21mm Barbed broaches #1
• 06970514912677: 21mm Barbed broaches #0
• 06970514911724: 21mm Stainless Steel PLUGGERS #15
• 06970514911557: 25mm PASTE CARRIERS #25
• 06970514910314: 25mm Niti K file(For hand) #10
• 06970514914305: 21mm Niti K file(For hand) #70
• 06970514918839: Super Files III 25mm SX-F3
• 06970514918624: Only One File Blue 25mm #25-#50
• 06970514912738: Barbed Broaches 21mm #6
• 06970514912721: Barbed Broaches 21mm #5
• 06970514919102: 21mm Super fileIII(Engine) SX-F3
• 06970514919096: 21mm Super fileIII(Engine) F5
• 06970514919089: 21mm Super fileIII(Engine) F4
• 06970514919072: 21mm Super fileIII(Engine) F3
• 06970514919065: 21mm Super fileIII(Engine) F2
• 06970514919058: 21mm Super fileIII(Engine) F1
• 06970514919041: 21mm Super fileIII(Engine) S2
• 06970514919003: 31mm Super fileIII(Engine) F5
• 06970514918990: 31mm Super fileIII(Engine) F4
• 06970514918983: 31mm Super fileIII(Engine) F3
• 06970514918976: 31mm Super fileIII(Engine) F2
• 06970514918952: 31mm Super fileIII(Engine) S2
• 06970514918945: 31mm Super fileIII(Engine) S1
• 06970514918815: 25mm Super fileIII(Engine) F4
• 06970514918808: 25mm Super fileIII(Engine) F3
• 06970514918792: 25mm Super fileIII(Engine) F2
• 06970514918785: 25mm Super fileIII(Engine) F1
• 06970514918778: 25mm Super fileIII(Engine) S2
• 06970514918761: 25mm Super fileIII(Engine) S1
• 06970514918747: 19mm Super file III (Engine) SX
• 06970514914411: 25mm Niti K file(For hand) #45-80
• 06970514914244: 21mm Niti K file(For hand) #35
• 06970514919034: 21mm Super fileIII(Engine) S1
• 06970514919010: 31mm Super fileIII(Engine) SX-F3
• 06970514918969: 31mm Super fileIII(Engine) F1
• 06970514918822: 25mm Super fileIII(Engine) F5
• 06970514918730: 25mm D-Super file(Engine) SX-F3
• 06970514919317: 21mm D-Shaper Assorted
• 06970514919379: 25mm D-Shaper Assorted
• 06970514919287: 31mm D-Super file(Engin) SX-F3
• 06975718055380: Gutta Percha Pluggers #60-#120
• 06975718055373: Gutta Percha Pluggers #50-#100
• 06975718055366: Gutta Percha Pluggers #40-#80
• 06975718055359: Gutta Percha Pluggers #35-#70
• 06975718055342: Micro Scope H Files #15-40