3D Endo HN2525

GUDID 00810126500519

Hedstrom Files NiTi 25mm #25 6/Pk

3D DENTAL DESIGNS AND DEVELOPMENT, LLC

Manual endodontic file/rasp, single-use

• Primary Device ID: 00810126500519
• NIH Device Record Key: 4cc6ef35-a926-404b-acd2-d28769bce2e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Endo
• Version Model Number: HN2525
• Catalog Number: HN2525
• Company DUNS: 080194935
• Company Name: 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
• 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: false
• 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	00810126500519 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

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

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

[00810126500519]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-22
• Device Publish Date: 2023-02-14

On-Brand Devices [3D Endo]

• 00810126500625: Hedstrom Files NiTi31mm #08 6/Pk
• 00810126500618: Hedstrom Files NiTi 25mm #80 6/Pk
• 00810126500601: Hedstrom Files NiTi 25mm #70 6/Pk
• 00810126500588: Hedstrom Files NiTi 25mm #55 6/Pk
• 00810126500571: Hedstrom Files NiTi 25mm #50 6/Pk
• 00810126500564: Hedstrom Files NiTi 25mm #45-80 6/Pk
• 00810126500557: Hedstrom Files NiTi 25mm #45 6/Pk
• 00810126500540: Hedstrom Files NiTi 25mm #40 6/Pk
• 00810126500533: Hedstrom Files NiTi 25mm #35 6/Pk
• 00810126500526: Hedstrom Files NiTi 25mm #30 6/Pk
• 00810126500519: Hedstrom Files NiTi 25mm #25 6/Pk
• 00810126500502: Hedstrom Files NiTi 25mm #20 6/Pk
• 00810126500496: Hedstrom Files NiTi 25mm #15-40 6/Pk
• 00810126500489: Hedstrom Files NiTi 25mm #15 6/Pk
• 00810126502537: K-File SS 31mm #80 6/Pk
• 00810126502520: K-File SS 31mm #70 6/Pk
• 00810126502513: K-File SS 31mm #60 6/Pk
• 00810126502506: K-File SS 31mm #55 6/Pk
• 00810126502490: K-File SS 31mm #50 6/Pk
• 00810126502483: K-File SS 31mm #45-80 6/Pk
• 00810126502476: K-File SS 31mm #45 6/Pk
• 00810126502469: K-File SS 31mm #40 6/Pk
• 00810126502452: K-File SS 31mm #35 6/Pk
• 00810126502445: K-File SS 31mm #30 6/Pk
• 00810126504487: Gutta Percha Points Box/60/Tapered .06 #35
• 00810126504463: Gutta Percha Points Box/60/Tapered .06 #25
• 00810126504432: Gutta Percha Points Box/60/Tapered .06 #15
• 00810126504265: Gutta Percha Points Box/60/Tapered .04 #15
• 00810126504258: Gutta Percha Points Box/120 Vial Pack #45-80
• 00810126504234: Gutta Percha Points Box/120 Vial Pack #45
• 00810126504227: Gutta Percha Points Box/120 Vial Pack #40
• 00810126504210: Gutta Percha Points Box/120 Vial Pack #35
• 00810126504203: Gutta Percha Points Box/120 Vial Pack #30
• 00810126504197: Gutta Percha Points Box/120 Vial Pack #25
• 00810126504180: Gutta Percha Points Box/120 Vial Pack #20
• 00810126504173: Gutta Percha Points Box/120 Vial Pack #15-40
• 00810126504166: Gutta Percha Points Box/120 Vial Pack #15
• 00810126504159: Gutta Percha Points Vials 60/Pk #140
• 00810126504142: Gutta Percha Points Vials 60/Pk #130
• 00810126504135: Gutta Percha Points Vials 60/Pk #120
• 00810126504128: Gutta Percha Points Vials 60/Pk #110
• 00810126504111: Gutta Percha Points Vials 60/Pk #100
• 00810126504104: Gutta Percha Points Box/120 Vial Pack #10
• 00810126503299: Gutta Percha Points Box/120 #15-40
• 00810126503282: Gutta Percha Points Box/120 #15
• 00810126503275: Gutta Percha Points Box/60/Tapered .06 #40
• 00810126503268: Gutta Percha Points Box/60/Tapered .06 #20
• 00810126503190: Gutta Percha Points Box/60/Tapered .04 #40
• 00810126503183: Gutta Percha Points Box/60/Tapered .04 #35
• 00810126503138: Reamers SS 31mm #80 6/Pk