Safesider HF 5121-01

GUDID 00766054002765

Safesider HF Glidepath Refill 21 mm

ESSENTIAL DENTAL SYSTEMS, INC.

Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable Rotary/reciprocating endodontic file/rasp, reusable

• Primary Device ID: 00766054002765
• NIH Device Record Key: ad9b5fe6-23b8-4291-83bc-0ffea03aa6eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safesider HF
• Version Model Number: 5121-01
• Catalog Number: 5121-01
• Company DUNS: 101147171
• Company Name: ESSENTIAL DENTAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com
• Phone: +1(201)487-9090
• Email: udi@edsdental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00766054002765 [Primary]

FDA Product Code

• EKP: REAMER, PULP CANAL, ENDODONTIC

Sterilization

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

[00766054002765]

Moist Heat or Steam Sterilization

[00766054002765]

Moist Heat or Steam Sterilization

[00766054002765]

Moist Heat or Steam Sterilization

[00766054002765]

Moist Heat or Steam Sterilization

[00766054002765]

Moist Heat or Steam Sterilization

[00766054002765]

Moist Heat or Steam Sterilization

[00766054002765]

Moist Heat or Steam Sterilization

[00766054002765]

Moist Heat or Steam Sterilization

[00766054002765]

Moist Heat or Steam Sterilization

[00766054002765]

Moist Heat or Steam Sterilization

[00766054002765]

Moist Heat or Steam Sterilization

[00766054002765]

Moist Heat or Steam Sterilization

[00766054002765]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-27
• Device Publish Date: 2020-07-17

On-Brand Devices [Safesider HF]

• 00766054002833: SafeSiders HF Gutta Percha 30/04
• 00766054002826: SafeSiders HF Gutta Percha 25/04
• 00766054002819: Safesider HF Glidepath Refill 25 mm
• 00766054002802: Safesider HF Shaper Refill 25 mm
• 00766054002796: Safesider HF Finisher Refill 25 mm
• 00766054002789: Safesider HF Finisher Refill 21 mm
• 00766054002772: Safesider HF Shaper Refill 21 mm
• 00766054002765: Safesider HF Glidepath Refill 21 mm
• 00766054002758: Safesider HF Intro Kit 25 mm
• 00766054002741: Safesider HF Intro Kit 21 mm