EDTA 162

GUDID 00883205105431

EDTA 18% Solution IndiSpense Refill

ULTRADENT PRODUCTS, INC.

Endodontic reaming aid material

• Primary Device ID: 00883205105431
• NIH Device Record Key: e07b8a78-c1cd-4888-b5eb-fc1dbcdb49b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDTA
• Version Model Number: 162
• Catalog Number: 162
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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(801)572-4200
• Email: customerservice@ultradent.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205105431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934415

FDA Product Code

• KJJ: CLEANSER, ROOT CANAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-10

On-Brand Devices [EDTA]

• 00883205106711: EDTA 18% Bottle 16oz
• 00883205105431: EDTA 18% Solution IndiSpense Refill