Consepsis 404

GUDID 00883205105615

Consepsis IndiSpense Kit

ULTRADENT PRODUCTS, INC.

Dental tooth-cleaning solution

• Primary Device ID: 00883205105615
• NIH Device Record Key: 621daa59-b763-4d89-a1ce-42e422a63255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Consepsis
• Version Model Number: 404
• Catalog Number: 404
• 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: true
• 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	00883205105615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924982

FDA Product Code

• LBH: VARNISH, CAVITY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-05
• Device Publish Date: 2016-09-22

On-Brand Devices [Consepsis]

• 00883205106704: Consepsis Bottle 16oz
• 00883205106322: Consepsis V IndiSpense Refill
• 00883205105912: Consepsis Scrub IndiSpense Refill
• 00883205105905: Consepsis IndiSpense Refill
• 00883205105820: Consepsis Scrub IndiSpense Kit
• 00883205105615: Consepsis IndiSpense Kit
• 00883205103789: Consepsis Scrub Kit
• 00883205103772: Consepsis Scrub Refill
• 00883205103581: Consepsis Kit
• 00883205102669: Consepsis Econo Refill
• 00883205102607: Consepsis Unit Dose 50pk