SafeSiders 5031-00

GUDID 00766054000990

SafeSiders Intro Kit 31 mm

ESSENTIAL DENTAL SYSTEMS, INC.

Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable Manual endodontic file/rasp, reusable

• Primary Device ID: 00766054000990
• NIH Device Record Key: 29a88cfc-d79e-467b-bfec-2b7682fa93f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeSiders
• Version Model Number: 5031-00
• Catalog Number: 5031-00
• 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: false
• Serial Number: true
• 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	00766054000990 [Primary]

FDA Product Code

• EKP: REAMER, PULP CANAL, ENDODONTIC

Sterilization

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

[00766054000990]

Moist Heat or Steam Sterilization

[00766054000990]

Moist Heat or Steam Sterilization

[00766054000990]

Moist Heat or Steam Sterilization

[00766054000990]

Moist Heat or Steam Sterilization

[00766054000990]

Moist Heat or Steam Sterilization

[00766054000990]

Moist Heat or Steam Sterilization

[00766054000990]

Moist Heat or Steam Sterilization

[00766054000990]

Moist Heat or Steam Sterilization

[00766054000990]

Moist Heat or Steam Sterilization

[00766054000990]

Moist Heat or Steam Sterilization

[00766054000990]

Moist Heat or Steam Sterilization

[00766054000990]

Moist Heat or Steam Sterilization

[00766054000990]

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 [SafeSiders]

• 00766054001232: Steri-Tracker
• 00766054001225: SafeSiders Endo Stops
• 00766054001133: SafeSiders Pleezer Reamer
• 00766054001126: SafeSiders Peeso Reamer Size No. 3 - 19 mm Cutting Length
• 00766054001119: SafeSiders Peeso Reamer Size No. 2 - 19 mm Cutting Length
• 00766054001102: SafeSiders Refill Size 25/06 31 mm NiTi
• 00766054001096: SafeSiders Refill Size 30/04 31 mm NiTi
• 00766054001089: SafeSiders Refill Size .40 31 mm
• 00766054001072: SafeSiders Refill Size .35 31 mm
• 00766054001065: SafeSiders Refill Size .30 31 mm
• 00766054001058: SafeSiders Refill Size .25 31 mm
• 00766054001041: SafeSiders Refill Size .20 31 mm
• 00766054001034: SafeSiders Refill Size .15 31 mm
• 00766054001027: SafeSiders Refill Size .10 31 mm
• 00766054001010: SafeSiders Refill Size .08 31 mm
• 00766054001003: SafeSiders Refill Size .06 31 mm
• 00766054000990: SafeSiders Intro Kit 31 mm
• 00766054000983: SafeSiders Glide Path 25 mm
• 00766054000976: SafeSiders Intro Kit 25 mm
• 00766054000969: SafeSiders Refill Size .40 25 mm
• 00766054000952: SafeSiders Refill Size .35 25 mm
• 00766054000945: SafeSiders Refill Size .30 25 mm
• 00766054000938: SafeSiders Refill Size .25 25 mm
• 00766054000921: SafeSiders Refill Size .20 25 mm
• 00766054000914: SafeSiders Refill Size .15 25 mm
• 00766054000907: SafeSiders Refill Size .10 25 mm
• 00766054000891: SafeSiders Refill Size .08 25 mm
• 00766054000884: SafeSiders Refill Size .06 25 mm
• 00766054000877: SafeSiders Refill Size 25/06 25 mm NiTi
• 00766054000860: SafeSiders Refill Size 25/08 25 mm NiTi
• 00766054000853: SafeSiders Refill Size 30/04 25 mm NiTi
• 00766054000846: SafeSiders Refill Size 30/04 21 mm NiTi
• 00766054000839: SafeSiders Refill Size 25/08 21 mm NiTi
• 00766054000822: SafeSiders Refill Size 25/06 21 mm NiTi
• 00766054000815: SafeSiders Refill Size .40 21 mm
• 00766054000808: SafeSiders Refill Size .35 21 mm
• 00766054000792: SafeSiders Refill Size .30 21 mm
• 00766054000785: SafeSiders Refill Size .25 21 mm
• 00766054000778: SafeSiders Refill Size .20 21 mm
• 00766054000761: SafeSiders Refill Size .15 21 mm
• 00766054000754: SafeSiders Refill Size .10 21 mm
• 00766054000747: SafeSiders Refill Size .08 21 mm
• 00766054000730: SafeSiders Refill Size .06 21 mm
• 00766054000723: SafeSiders Intro Kit 21 mm
• 00766054000716: SafeSiders Glide Path 21 mm